(183 days)
It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "Modern Medical Non Stick Electrode." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table and study details from the given text.
The information I can extract, which is not directly related to acceptance criteria or performance studies but is present in the document, includes:
- Trade/Device Name: Modern Medical Non Stick Electrode
- Regulation Number: 21 CFR 878.4400
- Regulation Name: Electrosurgical cutting and coagulation device and accessories
- Regulatory Class: II
- Product Code: GEI
- Indications For Use: It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
- 510(k) Number: K043036
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 6 2005
Modern Medical Equipment MFG., Ltd. C/o Mr. Robert Stillman E & M Engineering Incorporated 1705 Dabney Road Richmond, Virginia 23230
Re: K043036
Trade/Device Name: Modern Medical Non Stick Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23 , 2004 Received: April 12, 2005
Dear Mr. Stillman:
We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave ro rowed your ve determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated) 7 the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de nees mat have been that do not require approval of a premarket approval application (PMA). and Cosmetic fore, market the device, subject to the general controls provisions of the Act. The r ou may, are ex vrovisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your doviee is elassified (disalated). Existing major regulations affecting your device it may of subject to saon af Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA oun or found in the announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be advisou that I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I ederal all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set El It i at 6077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quinny by our of provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Robert Stillman
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will and w you to begin mating of substantial equivalence of your device to a legally premation notificate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific aarroliance at (240) 276-0115 . Also, please note the regulation entitled, Contact the Oriece of Collect of Colling to the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
| Applicant: | Modern Medical Equipment Mfg. Ltd. |
|---|---|
| 510(k) Number | Not assigned yet K043036 |
| Device Name: | Modern Medical Non Stick Electrode |
Indications For Use:
It is an electrosurgical cutting and coagulating device intended to remove tissues and control bleeding by means of high frequency electrical current.
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Prescription Use V AND/OR Over-The-Counter Use (Part 21 CFR 807 sub-part C (Part 21 CFR 801 sub-part D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
0120170
043036
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.