(459 days)
The instrument is used to cut and coagulate the selected tissue for Laparoscopic procedure.
Not Found
This document is a letter from the FDA regarding clearance for "Laparoscopic Instruments and Electrode Tips" and an "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving how the device meets those criteria. Therefore, I cannot extract the requested information from the provided text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2004
Mr. David Lou Senior Project Engineer Modern Medical Equipment Manufacturing Ltd. 5F, Gold King Ind. Bldg. 35 Tai Lin Pai Road Kwai Chung, N.T. Hong Kong
Re: K030831
Trade/Device Name: Laparoscopic Instruments and Electrode Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 9, 2004 Received: April 13, 2004
Dear Mr. Lou:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 entressary of the enactment date of the Medical Device Amendments, or to eonimer of they to ria) 2011-07-11 in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, interest, mains of the Act include requirements for annual registration, listing of general controll proficturing 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 n your device to such additional controls. Existing major regulations affecting your device can may or sabject to back as a saceral Regulations, Title 21, Parts 800 to 898. In addition, I·DA 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 I that FDA has made a determination that your device complies with other requirements of the Act mar I Dr has made a and regulations administered by other Federal agencies. You must or any I odetar states and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. David Lou
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
Indications for Use:
Laparoscopic Instruments and Electrode Tips
The instrument is used to cut and coagulate the
selected tissue for Laparoscopic procedure.
Prescription Use √
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
or
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off)
Division of General, Restorativ and Neurological Devices
510(k) Number_KO3083)
§ 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.