The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures. The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths. Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion. When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site. The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called CORE-SNARE. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the context of an AI/ML powered device.

Therefore, the document does not contain the information requested in your prompt regarding:

A table of acceptance criteria and reported device performance for an AI/ML algorithm.
Sample sizes, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML test set.
MRMC studies or standalone AI performance.
Training set details for an AI/ML algorithm.

The document primarily details the non-clinical performance testing to demonstrate the physical, electrical, and material safety and effectiveness of the CORE-SNARE, which is an electrosurgical snare for polyp removal.

Here's what the document does provide regarding its "acceptance criteria" and "study":

Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)

The "acceptance criteria" in this context are the limits and standards the physical device must meet during various non-clinical tests to be considered safe and effective and substantially equivalent to the predicate. The "study" refers to the bench testing performed.

Test Item	Acceptance Criteria	Reported Device Performance
I. Physical/Dimensional Tests
Dimension Test	Tolerance of nominal size should be ±10% of the standard.	"All dimensional values do not exceed the tolerance of ±10%."
Tensile Strength: Electrode Cable	Shall not be damaged from 40 N pulling and 0.64 J impact (in accordance with ANSI/AAMI HF 18 (2001) 4.2.5.5).	"There was no damaged from 40 N pulling and 0.64 J impact."
Tensile Strength: Inner Rope-Cutting Wire	Strength between inner rope and cutting wire should be not less than 15 lbs.	"It was confirmed the strength is more than 15 lbs."
Tensile Strength: Catheter Sheath-Handle	Strength between catheter sheath and handle should be not less than 2 lbs.	"There was more than 2 lbs."
II. Electrical Tests
Cable Withstand Voltage (Main frequency)	Must withstand a peak voltage of 1000V (large DC or Mains frequency) for 5 minutes (for rated accessory voltage).	"The proposed device was tested... and passed."
Cable Withstand Voltage (High frequency)	Must withstand for 30 seconds at a high frequency voltage of 120% of the rated accessory voltage (Maximum voltage of accessory is 920 Vp).	"The proposed device was tested... and passed."
High Frequency Leakage Current	Monopolar high-frequency leakage current of electrode cable shall not be more than 3.6 dfL mA; connection cord unwrapped/undamaged; no short circuits between individual conductors for multiconductor cables (in accordance with ANSI/AAMI HF 18(2001) 4.2.5.2).	"The proposed device was tested... and passed."
Conductive Inspection (Continuity Test)	Tips for connection with electrode tip must be electrically connected to each other (using electrical conduction circuit system).	"The proposed device was tested... and passed."
III. Sterility/Biocompatibility/Shelf Life
Sterility	Demonstrates a 10^-6^ SAL (Sterility Assurance Level) following ISO 11135. No microbial growth found. Meets ISO 10993-7 for ethylene oxide sterilization residuals.	"A sterility validation was completed following ISO 11135 requirements to demonstrate a 10^-6^ SAL." "No evidence of microbial growth is found, the test article to be examined complies with sterility test." Meets ISO 10993-7.
Biocompatibility	Passed tests for Cytotoxicity, Maximization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen test (in accordance with ISO 10993-1 for tissue contact < 24 hours).	"The proposed device passed all biocompatibility tests." Specific tests listed (Cytotoxicity, Maximization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen test) were performed.
Physical/Chemical Extraction Test	Acceptable levels for Appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal (accordance with In-house hold standards).	"Test items are Appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal are acceptable level."
Shelf Life (Accelerated Aging)	Demonstrated product integrity over a 3-year lifespan (in compliance with ASTM F1980).	"Accelerated aging studies for start and three(3) years were performed to determine product integrity over its lifespan, with acceptable results." (Real-time study is in process to verify). Claimed max shelf life is 3 years.

Other Requested Information (Not Applicable or Not Present for This Device)

Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device relying on a clinical test set from patient data. The "test set" here refers to the physical devices manufactured for bench testing, but specific numbers are not given for each test, only that "the proposed device was tested" or the "test article" was examined. Data provenance is therefore also not applicable in the AI/ML context.
Number of experts used to establish the ground truth... and qualifications: Not applicable, as this is not an AI/ML device requiring expert annotation of medical images/data.
Adjudication method for the test set: Not applicable for a physical medical device.
MRMC comparative effectiveness study... effect size: Not applicable for a physical medical device.
Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for a physical medical device.
The type of ground truth used: Not applicable for a physical medical device. The "ground truth" for this device's performance is established by industrial and electrical engineering standards (e.g., tensile strength, withstand voltage) and biological safety standards (e.g., sterility, biocompatibility).
The sample size for the training set: Not applicable for a physical medical device.
How the ground truth for the training set was established: Not applicable for a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 21, 2022

Incore Co., Ltd. Jae-Hun Lee Department head of Regulatory Affairs 11, Hyeoksin-daero, 78-gil, Dong-gu Daegu, 41072 KOREA, SOUTH

Re: K220846

Trade/Device Name: Core-Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: FDI Dated: March 15, 2022 Received: March 23, 2022

Dear Jae-Hun Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Sivakami Venkatachalam -S

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220846

Device Name CORE-SNARE

Indications for Use (Describe)

The CORE-SNARE is used endoscopically in the removal of diminutive polyps, pedunculated polyps and tissue from within the GI tract.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the words CORE-SNARE in large, bold, black font. Below that, the words Traditional 510(K) are written in a smaller, bold, black font. The image is simple and contains only text.

Image /page/3/Picture/2 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side, with the word "INCORE" in bold, sans-serif font to the right. Below the word "INCORE" is a thin line, and below that is the text "innovative core technologies of medical devices" in a smaller font size.

Section 5 - 510(K) Summary

In accordance with the Food and Drug Adminstration Rule to implement provisions of the Safe Medical Device Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the CORE-SNARE.

I. Submitted by

Company Name : INCORE CO.,LTD. Company Address : 11, Hyeoksin-daero 78-gil, Dong-gu, Daegu, Republic of Korea

Contact Person : Mr. Jae-Hun, Lee Department head of Regulatory Affairs

Contact Phone : (82) 2-866-3514 Contact Fax : (82) 2-6919-1346

Date of Preparation : March 15, 2022

II. Device

Trade of Device : CORE-SNARE

Model : IC-SN0210, IC-SN0215, IC-SN0310, IC-SN0315, IC-SN0324, IC-SN0330, IC-SN0410, IC-SN0413, IC-SN0415, IC-SN0424, IC-SN0430, IC-SN3310, IC-SN3313, IC-SN3315, IC-SN3324, IC-SN3330, IC-SN0410CR, IC-SN0415CR, IC-SN0424CR, IC-SNR0210, IC-SNR0215, IC-SNR0310, IC-SNR0313, IC-SNR0315, IC-SNR0324, IC-SNR0410, IC-SNR0413, IC-SNR0415, IC-SNR0424, IC-SNR0330, IC-SNR0430, IC-SNR3310, IC-SNR3313, IC-SNR3315, IC-SNR3324, IC-SNR3330, IC-SNR0410CR, IC-SNR0415CR, IC-SNR0424CR
Common or Usual Name : Disposable electrically-operated medical snare Classification Name : Endoscopic Electrosurgical Unit and Accessories Device Product Code : FDI Review Panel : Gastroenterology/Urology Regulation Number: 21 CFR 876.4300 Endoscopic Electrosurgical Unit and Accessories. Regulatory Class : Class II

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Image /page/4/Picture/1 description: The image shows the logo for "INCORE", with the tagline "innovative core technologies of medical devices" underneath. To the left of the text is a graphic of three overlapping circles, with the intersection of the circles filled in with a darker color. The text is in a sans-serif font and is black in color. The tagline is in a smaller font size than the main logo.

Ⅲ, Predicate Device

Device Name : ClearGrasp Snare Manufacturer : Finemedix Co. Ltd 510(K) Number : K183289 Classification Name : Endoscopic Electrosurgical Unit and Accessories Product Code : FDI Regulatory Class : Class II Regulation Number: 21 CFR 876.4300 Endoscopic Electrosurgical Unit and Accessories.

The predicates have not been subject to a design-related recall. No reference devices were used in this submission.

IV. Device Description

The CORE-SNARE is a disposable device for cuts out and removes the tissues such as polyps after entering a site to be treated during endoscopic procedures.

The device consists of Snare-loop connected with catheter tube and Catheter tube pass through operating channel of endoscope and Handle connected with snare through the catheter tube. It is available in various sizes and working lengths.

Users can choose an Oval or a Crescent or Diamond type based on their preference and the characteristic of the loop sizes can be chosen in accordance with the size of the lesion and the rotational type helps approaching and grasping the lesion.

When connected to an electrosurgical generator and activated, the loop delivers a monopolar electrical current to the surgical site.

The proposed product is packed in a sealed pouch following EO Sterilization (SAL 10t%). This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

V. Indications for Use

The CORE-SNARE is used endoscopically in the removal of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

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Image /page/5/Picture/1 description: The image shows the logo for INCORE, a company that specializes in innovative core technologies for medical devices. The logo features a stylized graphic of overlapping circles in the upper left corner, followed by the company name in bold, sans-serif font. Below the name is a tagline that describes the company's focus on innovative core technologies for medical devices. The overall design is clean and modern, conveying a sense of innovation and expertise.

VI. Comparison of Technological Characteristics with predicate device

The CORE-SNARE has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Finemedix CO.,Ltd's ClearGrasp Snare, K183289. the differences between the proposed device and the predicated devices do not raise any questions regarding its safety and effectiveness. the differences are listed in the table below.

The following tests evaluate the substantial equivalence of the subject device through the performance test applying the same standard as the predicate device.

Performance testing such as appearance, dimension, continuity, tensile strength test of electrode cable, withstand voltage, high frequency leakage current test of electrode cable according to IEC 60601-2-2:2017 and ANSI/AAMI HF18:2001. The test results show that the subject device is substantially equivalent to the predicate device.

Item	Proposed Device	Predicate Device	SubstantialEquivalence
Classficationregulation	CORE-SNARE	ClearGrasp Snare
	21 CFR 876.4300	21 CFR 876.4300	Same
Classificationand Code	Class II , FDI	Class II , FDI	Same
DeviceClassficationName	Endoscopic ElectrosurgicalUnit and Accessories	Endoscopic ElectrosurgicalUnit and Accessories	Same
510(K) number	K220846	K183289	-
Indications forUse	The CORE-SNARE isused endoscopically in theremoval of diminutivepolyps, sessile polyps,pedunculated polyps andtissue from within the GItract.	The ClearGrasp Snare isused endoscopically in theremoval of diminutivepolyps, sessile polyps,pedunculated polyps andtissue from within the GItract.	Same
Configuration	Loop, Catheter Tube,Handle(Slider, Body)	Loop, Catheter Tube,Handle, Slider, Plug	Similar

Table 1 : Comparison to Predicate Device
------------------------------------------	--

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Image /page/6/Picture/1 description: The image shows the logo for INCORE. The logo consists of a circular graphic to the left of the word "INCORE". The graphic is made up of three overlapping circles, with the intersection of the circles colored in blue. Below the word "INCORE" is a thin black line, and below that is some smaller text that is difficult to read.

	Loop	SUS 304	SUS 304
Material	CatheterTube	PTFE	PTFE	Same
	Handle	ABS	ABS
		Shape of Loop	Oval and Crescent andDiamond	Oval and Crescent
	Working Length	2200, 2400mm	1600, 1800, 2200, 2400mm	Similar
	Loop Size	10, 15, 24, 30mm	6,10,13,15,24,30 mm	Similar
	Rotational/Non-Rotational	Both	Both	Same
	Sterilization	EO Sterilization	EO Sterilization	Same
	Single Use	Yes	Yes	Same
	Used withElectrosurgicalUnit	Yes	Yes	Same

VII. Non-clinical testing data

1) Sterility

A sterility validation was completed following ISO 11135 requirements to demonstrate a 10° SAL. And the proposed device meets the requirements of ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"

The Sterility test is tested with a direct method.

No evidence of microbial growth is found, the test article to be examined complies with sterility test.

2) Biocompatibility Testing

Biocompatibility testing has been performed in accordance with ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

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Image /page/7/Picture/1 description: The image shows the logo for INCORE. The logo consists of three overlapping circles on the left side, with the word "INCORE" in bold, sans-serif font to the right. Below the word "INCORE" is a tagline in a smaller font that reads "Innovative core technologies of medical devices."

The CORE-Snare is considered tissue contacting for a duration of less than 24 hours.

The proposed device passed all biocompatibility tests.

In accordance to ISO10993-1, the following biocompatibility tests were performed : Cytotoxicity, Maximization, Intractutaneous Reactivity, Acute Systemic Toxicity, Pvrogen test.

3) Performance Testing

(1) Demension test

When measured by vernier calipers, the tolerance of the nominal size should be ±10 % of the stndard. For the dimensional test, all dimensions of the core-snare non-rotation type product were measured. As a result of the measurement, it was confirmed that all dimensional values do not exceed the tolerance of ±10%. Therefore, the CORE-SNARE meets the performance required by demension test.

(2) Tensile strength test

(1) Electrode Cable

The tensile strength test method for Electrode Cable was performed in accordance with ANSI/AAMI HF 18 (2001) 4.2.5.5, and according to method, Electrode cables and connecting parts shall not be damaged from 40 N pulling and 0.64 J impact. The proposed device was tested, and there was no damaged from 40 N pulling and 0.64 J impact.

Therefore, the CORE-SNARE meets the performance required by tensile strength of electrode cable.

(2) Inner rope-cutting wire

The tensile strength (inner rope-cutting wire) was tested as follows.

The cutting knife is cut out from the sheath by manipulating the handle. The inner rope and the cutting wire are cut at a position of about 15cm from the end to make a specimen, and the specimen is pulled at a rate of 1.0 in/min.

Under the conditions of the above method, the strength between the inner rope and the cutting wire should be not less than 15 lbs.

The proposed device was tested, and It was confirmed the strength is more than 15 lbs.

Therefore, the CORE-SNARE meets the performance required by tensile strength of

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Image /page/8/Picture/2 description: The image shows the logo for INCORE. The logo features a graphic of three overlapping circles on the left side. To the right of the graphic is the word "INCORE" in large, bold, sans-serif font. Underneath the word "INCORE" is a thin line, and below that is some smaller text that is difficult to read.

inner rope-cutting wire.

3 Catheter sheath-handle

The tensile strength (catheter sheath-handle) was tested as follows. After manipulating the handle, pull out the cutting knife out of the sheath, cut the sheath and cable at 2 inches of the distal end of the strain relief to make a specimen, and pulled at a rate of 1.0 in/min. Under the conditions of the above method, the strength between the catheter sheath and the handle should be not less than 2 lbs. The proposed device was tested, and there was more than 2 bs. Therefore, the CORE-SNARE meets the performance required by tensile strength of catheter sheath-handle.

(3) Cable Withstand voltage
The main frequency withstand voltage meets the test criteria that the rate accessory voltage specified by the manufacturer of the high frequency surgical accessory must withstand a peak voltage of 1000V, large DC or Mains frequency for 5 minutes.

And the high-frequency withstand voltage must withstand for 30 seconds at high frequency voltage of 120% of the rated accessory voltage presented by the manufacturer. Maximum voltage of accessory is 920 Vp.

For the test, refer to the test method with the following IEC 60601-2-2:2011. The proposed device was tested according to the above criteria and passed. Therefore, the CORE-SNARE meets the performance required by Cable Withstand voltage.

(4) High Frequency leakage current test
High frequency leakage current testing has been performed in accordance with ANSI / AAMI HF 18(2001) 4.2.5.2.

The monopolar high-frequency leakage current of the electrode cable shall be not more than 3.6 dfL mA and, the connection cord shall not have worked loose nor shall it show any damage.

For multiconductor cables there shall be no short circuits betwwen individual conductors.

The proposed device was tested according to the above criteria and passed.

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Image /page/9/Picture/1 description: The image shows the logo for INCORE. The logo consists of a circular design on the left and the word "INCORE" in bold, sans-serif font on the right. Below the word "INCORE" is a thin line, and below that is some smaller text that is difficult to read. The circular design on the left appears to be three overlapping circles with a dark blue fill in the intersection.

Therefore, the CORE-SNARE meets the performance required by High frequency leakage current test

(5) Conductive Inspection (Continuity test)

This test is performed using electrical conduction circuit system, and tips for connection with electrode tip must be electrically connected to each other. The proposed device was tested according to the above criteria and passed. Therefore, the CORE-SNARE meets the performance required by Conductive inspection.

4) Physical/Chemical

Extraction Test is tested accordance with In-house hold.

Test items are Appearance, pH, KMnO4 Consumption, Evaporating residue, Ultraviolet absorption, Heavy metal are acceptable level.

5) Shelf Life Test

The CORE-SNARE has a maximum shelf life of 3 years from the date of sterilization. In compliance with the standard of ASTM F1980 ; Standard Guide For Accelerated Aging of Sterile Barrier System for Medical Device, accelerated aging studies for start and three(3) years were performed to determine product integrity over its lifespan, with acceptable results. A real-time aging study is currently in process to verify the result found in the accelerated aging studies.

VIII. Conclusion

The conclusion drawn from the technological characteristics is that the CORE-SNARE has been found to have a safety and efficacy profile that is substantially equivalent to the predicate device ClearGrasp Snare which is marketed for the same intended use.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).