The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray, and MRI.

Device Description

The LumiMARK™ Biopsy Site Marker implant component [subject device] is composed of a nitinol (nickel/titanium alloy) material versus HydroMARK™ Breast Biopsy Site Marker [predicate device] which is composed of titanium or stainless steel encapsulated in resorbable hydrogel. The marker is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that allows the marker to be inserted with direct puncture under ultrasound. The applicator system is of similar design and materials as the currently marketed Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].

LumiMARK™ Biopsy Site Markers will be available in three different shapes. These permanently visible, implantable markers will allow the physician to identify different biopsied sites under ultrasound, x-ray, and MRI. A similar marker device commercialized by Devicor Medical Products, Inc. is already available (under K212158), and this HydroMARK™ Breast Biopsy Marker [predicate].

The deployment system used for the LumiMARK™ Biopsy Site Marker device [subject] will be similar to the HydroMARK™ Breast Biopsy Site Marker [predicate] delivery system with minor design changes to the plunger assembly and cannula. The nitinol markers will be intended for direct puncture or insertion through another introducer needle that is already in the breast or axillary lymph node.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the LumiMARK™ Biopsy Site Marker, and asserts its substantial equivalence (SE) to a predicate device, the HydroMARK™ Breast Biopsy Site Marker (K212158).

However, the text does not contain information about acceptance criteria, reported device performance in those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training sets.

The document focuses on "Performance Testing" and "Biocompatibility Testing" as part of verification data to support substantial equivalence. For both categories, the reported result is "PASSED" and a general statement that "The results of all performance testing met acceptance criteria." However, the specific acceptance criteria themselves, and the quantitative performance metrics attained, are not detailed.

It also explicitly states that the "fundamental scientific technology when compared to the HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] has not changed," and that the "minor differences between the subject device and predicate device do not raise concerns of safety and effectiveness." This suggests that the demonstration of substantial equivalence relies heavily on the similarity to the already cleared predicate device, rather than extensive de novo clinical studies with detailed performance metrics.

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Category	Acceptance Criteria	Reported Device Performance
Performance Testing	Not explicitly detailed, but implied to be related to meeting "all system requirements."	PASSED
	(e.g., Marker Size, Deployment Force, Visibility - criteria not specified in text)	Met acceptance criteria
LumiMARK™ Risk Management	All risks reduced as far as possible; no unacceptable residual risks; benefits > risks.	PASSED
Biocompatibility	Not explicitly detailed, but aligned with ISO 10993 series standards.	PASSED
	(e.g., Chemical Characterization, Cytotoxicity, Sensitization, etc. - criteria not detailed)	Met acceptance criteria

2. Sample size used for the test set and the data provenance:

Not provided. The document states "Performance Testing was conducted," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. The testing described is primarily bench performance and biocompatibility, not clinical studies requiring expert ground truth establishment in the traditional sense for diagnostic AI tools.

4. Adjudication method for the test set:

Not applicable/Not provided. No clinical test set requiring adjudication by experts is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No such study was done or mentioned. This device is an implantable biopsy site marker, not an AI-powered diagnostic tool, so MRMC studies for AI assistance are not relevant to its clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not provided. This device is a physical implantable marker and does not involve an algorithm for standalone performance.

7. The type of ground truth used:

For "Performance Testing" and "Biocompatibility Testing," the "ground truth" would be established by objective measurements and adherence to specified scientific and engineering standards (e.g., mechanical properties, chemical composition, biological response) rather than expert consensus on medical images or pathology. The text indicates use of standards like ISO 13485, ISO 14971, and ISO 10993 series for these tests.

8. The sample size for the training set:

Not applicable/Not provided. This device is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable/Not provided. (As it's not an AI model, there's no training set or ground truth in this context.)

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 12, 2024

Devicor Medical Products, Inc. Katy Austin Regulatory Affairs Specialist 300 E-Business Way, Fifth Floor Cincinnati. Ohio 45241

Re: K232615

Trade/Device Name: LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU Dated: August 28, 2023 Received: December 15, 2023

Dear Katy Austin:

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 (the 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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.

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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, Tek N. Lamichhane -Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control 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) K232615

Device Name

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary-K232615

SUBMITTER [Per 807.92(a)(1)]

Sponsor/Manufacturer

Devicor Medical Products, Inc. 300 E. Business Way, Fifth Floor Cincinnati, OH 45241 U.S.A.

Establishment Registration Number 3008492462

Official Correspondent for Devicor Medical Products, Inc.

Katy Austin, Senior Regulatory Affairs Specialist Email: katy.austin@mammotome.com

Date Prepared

January 12, 2024

DEVICE [Per 807.92(a)(2)]

Device Trade/Proprietary Name:	LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape))
	LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape))
	LumiMARK™ Biopsy Site Marker (LM0215R (Rose Shape))
Regulation Description	Implantable Marker
Device Common or Usual Name:	Marker, Radiographic, Implantable
Device Regulatory Classification:	Class II
Device Classification Regulation:	21 CFR §878.4300
Product Code:	(NEU) – Marker, Radiographic, Implantable
Submission Type:	Traditional 510(k) Premarket Notification
Classification Panel:	General & Plastic Surgery
Premarket Review:	Surgical and Infection Control Devices (OHT4)Infection Control and Plastic Surgery Devices (DHT4B)

PREDICATE DEVICE [Per 807.92(a)(3)]

	The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] issubstantially equivalent (SE) to the Sponsor's own predicate devices:
	•Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker(K212158) [predicate device]
PredicateDevice	The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] issubstantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ BreastBiopsy Site Marker (K212158) [predicate device] in terms of similar Indications for Use/ Intended Use to mark tissue during or associated with a percutaneous breast biopsyprocedure, be visible under ultrasound for at least 6 weeks, and be permanently visibleby x-ray and MRI. The Devicor Medical Product, Inc. LumiMARK™ Biopsy Site Marker

The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] issubstantially equivalent (SE) to the Sponsor's own predicate devices:

•Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker(K212158) [predicate device]

PredicateDevice

The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] issubstantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ BreastBiopsy Site Marker (K212158) [predicate device] in terms of similar Indications for Use/ Intended Use to mark tissue during or associated with a percutaneous breast biopsyprocedure, be visible under ultrasound for at least 6 weeks, and be permanently visibleby x-ray and MRI. The Devicor Medical Product, Inc. LumiMARK™ Biopsy Site Marker

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(subject device) includes axillary lymph nodes in the Indications for Use/Intended Usestatement as a direct puncture device, also demonstrated in HydroMARK™ as clearedin K212158.
• Substantial equivalence (SE) of the subject device is based on substantiallyequivalent design, functionality, and performance characteristics as thepredicate device.

DEVICE DESCRIPTION [Per 807.92(a)(4)]

Product Code	Description	Shape
LM0215T	LumiMARK Biopsy Site Marker "Tulip shape"	Image: Tulip shape marker
LM0215L	LumiMARK Biopsy Site Marker "Lotus shape"	Image: Lotus shape marker
LM0215R	LumiMARK Biopsy Site Marker "Rose shape"	Image: Rose shape marker

This Traditional 510(k) is being submitted to introduce LumiMARK™ Biopsy Siter Markers to the marketplace as part of the Mammotome brand, and the fundamental scientific technology when compared to the HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] has not changed. Both subject and predicate will have 3 year/36 month shelf life.

A User Instructions & Operations Guide, and Safety Information Booklet will be provided for all LumiMARK™ Biopsy Site Markers.

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INDICATIONS FOR USE

[Per 807.92(a)(5)

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [Per 807.92(a)(6)]

The Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] based on the similar functional and performance characteristics of the subject device when compared to the predicate device. The minor differences between the subject device and predicate device do not raise concerns of safety and effectiveness.

A side-by-side comparison of the technological characteristics of the subject device and the predicate device, supports a determination of substantial equivalency (SE) per the table below.

LumiMARK Comparison to Predicate HydroMARK Breast Biopsy Site Marker (K212158)
RegulatoryInformation	Project NikeLumiMARK™ BiopsySite Marker [subject]	HydroMARK™ BreastBiopsy Site MarkerK212158	Comparison
Manufacturer	Devicor Medical ProductsDe Mexico S De RL De CV	Devicor Medical ProductsDe Mexico S De RL De CV	---
Device Trade orProprietaryName	LumiMARK™ Biopsy SiteMarker	HydroMARK™ BreastBiopsy Site Marker	---
510(k) Number	K232615	K212158	N/A
Device Class	Class II	Class II	Substantially Equivalent
DeviceClassificationName	Marker, Radiographic,Implantable	Marker, Radiographic,Implantable	Substantially Equivalent
Device CommonName	Implantable Marker	Implantable Marker	Substantially Equivalent
Product Code	(NEU) — Marker,Radiographic, Implantable	(NEU) — Marker,Radiographic, Implantable	Substantially Equivalent
RegulationNumber	21 CFR §878.4300	21 CFR §878.4300	Substantially Equivalent

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Design Features and Capabilities of the Device
Indications forUse	To mark tissue associatedwith a percutaneous breastbiopsy procedure, includingaxillary lymph nodes, and bepermanently visible underultrasound, x-ray and MRI.	To mark tissue during apercutaneous breastbiopsy procedure,including axillary lymphnodes, be visible underultrasound for at least 6weeks, and bepermanently visible by x-ray and MRI.	Substantially Equivalent
Prescription orOver-the-Counter (OTC)Use	Prescription	Prescription	Substantially Equivalent
Use Environment
Sterile	Yes	Yes	Same
Single-Use	Yes	Yes	Same
Design Features
Marker Material	Nitinol (50% Nickel, 50%Titanium)	Stainless Steel or Titaniummarker, surrounded byhydrogel	Substantially Equivalent
Marker Shape	Tulip (LM0215T)Lotus (LM0215L)Rose (LM0215R)	Barrel (T1, S1)Butterfly (T4)Open Coil (T3, S3)	Substantially Equivalent
Cannula Type	Rigid	Rigid	Substantially Equivalent
CannulaMaterial	Stainless Steel	Stainless Steel	Substantially Equivalent
Plunger RodMaterial	Stainless Steel	Stainless Steel	Substantially Equivalent
Plastic Handle	Plastic Polymer	Plastic Polymer	Substantially Equivalent
Plunger Lock	P Plastic Polymer	Plastic Polymer	Substantially Equivalent
Plastic PlungerButton	Plastic Polymer	Plastic Polymer	Substantially Equivalent
Shelf Life	3 years/36 months	3 years/36 months	Substantially Equivalent
Biocompatibilityresults	- ChemicalCharacterizationCytotoxicitySensitizationIrritationAcute SystemicToxicityPyrogenicitySubacute/ Chronic/Subchronic ToxicityImplantationGenotoxicityCarcinogenicity	- ChemicalCharacterizationCytotoxicitySensitizationIrritationAcute SystemicToxicityPyrogenicitySubacute/ Chronic/Subchronic ToxicityImplantationGenotoxicityCarcinogenicity	Substantially Equivalent
Performanceevaluation	- Marker SizeDeployment ForceVisibility	- Marker SizeDeployment ForceVisibility	Substantially Equivalent

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MR Testing Results
MR Status forMarker	MR Conditional	MR Conditional	Substantially Equivalent
MR Status forApplicator	MR Unsafe	MR Unsafe	Substantially Equivalent

SUMMARY OF VERIFICATION DATA AND VERIFICATION TEST CONCLUSIONS [Per 807.92(b)(1)(2)(3)]

Summary of Performance Testing

Performance Testing was conducted on the Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker [subject device] to confirm that the device meets all system requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker (K212158) [predicate device]. The following Verification Data was provided in support of the substantial equivalence (SE) determination.

Performance Testing
Performance Testing LumiMARK™	Test Results: PASSEDThe results of all performance testing met acceptance criteriaand are provided in support of the substantial equivalencedetermination.
LumiMARK™ Risk Management	Results: All risks have been reduced as far as possiblethrough allowed controls: Inherent safety by design,information for safety, and/or preventative measures.There are no unacceptable residual risks at this time. Theoverall residual risk arising from individual and cumulativerisk is acceptable. Benefits outlined are greater than therisks. The product is considered State-of-the-Art.
● FDA Recognized Testing Standards:○ ISO 13485:2016Certification - Medical Devices –Quality Management Systems –Requirements for Regulatory Purposesprocess for medical devices○ ISO 14971:2019 (Ed.3.0)– Medical Devices - Application of RiskManagement to Medical Devices	Conclusion Supporting Substantial Equivalence: The resultsof the design verification carried out within Devicor MedicalProduct's ISO 13485:2016 compliant Quality ManagementSystem conducted on the LumiMARK™ Biopsy Site Marker[subject device] demonstrates that the subject device is assafe and as effective as the legally marketed predicatedevice. This evidence in conjunction with the ISO 14971:2019compliant Risk Management process supports adetermination of substantial equivalence of the DevicorMedical Products, Inc. LumiMARK™ Biopsy Site Marker[subject device] when compared to the Devicor MedicalProducts Inc. HydroMARK™ Breast Biopsy Site Marker(K212158) [predicate devices].

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Biocompatibility Testing including:	Biocompatibility Testing
Chemical Characterization Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Material-Mediated Pyrogenicity Subacute/Subchronic/ Chronic Toxicity Implantation Effects Genotoxicity Carcinogenicity	Test Results: PASSEDThe results of these Non-Clinical Bench Performance Data are provided insupport of the substantial equivalence determination.
FDA Recognized Testing Standards:	Conclusion Supporting Substantial Equivalence:
ISO 10993-1:2018-BiologicalEvaluation of Medical Devices – Part 1:Evaluation and Testing Within a RiskManagement Process ISO 10993-3:2014 BiologicalEvaluation of Medical Devices – Part 3:Tests for Genotoxicity, carcinogenicityand reproductive toxicity ISO 10993-5:2009-BiologicalEvaluation of Medical Devices – Part 5:Tests for In Vitro Cytotoxicity ISO 10993-6:2016-BiologicalEvaluation of Medical Devices – Part 6:Tests for local effects afterimplantation ISO 10993-10:2010-BiologicalEvaluation of Medical Devices – Part10: Tests for Irritation and SkinSensitization ISO 10993-11:2017-BiologicalEvaluation of Medical Devices – Part11: Tests for Systemic Toxicity ISO 10993-17:2002 BiologicalEvaluation of Medical Devices – Part17: Establishment of allowable limitsfor leachable substances ISO 10993-18:2020 BiologicalEvaluation of Medical Devices – Part18: Chemical characterization ofmedical device materials within a riskmanagement process ISO 10993-23:2021 BiologicalEvaluation of Medical Devices – Part23: Tests for Irritation	The results of theBiocompatibility Testing conducted on the Devicor Medical Products, Inc.HydroMARK Breast Biopsy Site Marker [subject device] demonstrates thatthe subject device is as safe, as effective, and performs as well as, thelegally marketed predicate device. This testing supports a determination ofsubstantial equivalence (SE) of the Devicor Medical Products, Inc.HydroMARK Breast Biopsy Site Marker [subject device] when compared tothe Devicor Medical Products, Inc. HydroMARK Breast Biopsy Site Marker(K212158) [predicate device].
Conclusion: The results of the Verification Testing support the safety of the device and demonstrate that the

requirements and is substantially equivalent (SE) to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].

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SUBSTANTIAL EQUIVALENCE SUMMARY / CONCLUSIONS

Based on the verification results and a side-by-side comparison of the technological characteristics of design, indication for use / intended use, components, and materials of construction, it is concluded that the Devicor Medical Products, Inc. LumiMARK™ Biopsy Site Marker (K232615) [subject device] is substantially equivalent to the Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.