(231 days)
Suction coagulator is used for coagulating tissue and removing fluid and debris from Suction coagulation is assulation can be performed independently or simultaneously.
Suction Coagulator
This letter is a 510(k) clearance for a Suction Coagulator, indicating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only specifies the indications for use for the device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2004
Mr. David Lou Senior Project Engineer Modern Medical Equipment Mfg. Ltd. 5F, Gold King Ind. Building 35 Tai Lin Pai Road Kwai Chung, Hong Kong
Re: K033003
Trade/Device Name: Suction Coagulator 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 roved your betermined 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 10 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. The r owneral controls provisions 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 cither class II (Special Controls) or class III (PMA), it may be subject to such 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 mcan 1 was o oe arr 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 or uny I with 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 OFF 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) I mis letter will and w yourse over finding of substantial equivalence of your device to a legally premarket notineteem. " 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 in you t 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 other general 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
Sincercly 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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Indications for Use
510(k) Number (if known): K033003
Device Name: Suction Coagulator
Indications For Use:
Suction coagulator is used for coagulating tissue and removing fluid and debris from Suction coagulation is assulation can be performed independently or simultaneously.
Prescription Use __ ブ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K 6330Q3
§ 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.