VISU-LOCK 5MM CLIP APPLIER

K033161 · Gyrx, LLC · FZP · Dec 18, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K033161
• Device Name: VISU-LOCK 5MM CLIP APPLIER
• Applicant: Gyrx, LLC
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Dec 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Visu-Loc™ 5mm Clip Applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Device Story

Visu-Loc 5mm Clip Applier is a surgical instrument used for ligation of tubular structures or vessels. Operated by surgeons in laparoscopic or general surgical settings. Device functions as a mechanical clip applier to secure tissue or vessels. Benefits include reliable ligation during surgical procedures. No electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical instrument for clip application. Designed for 5mm diameter applications. No energy source, software, or electronic components. Materials and sterilization methods are consistent with standard surgical clip appliers.

Indications for Use

Indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures for patients requiring surgical intervention.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embraced by a bird-like form. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 9 - 2004

Mr. Brian S. Zimovan Engineering Manager Gyrx, LLC 1122 St. Johns Industrial Parkway Jacksonville, Florida 32246

Re: K033161

Trade/Device Name: Visu-Lock 5mm Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: September 29, 2003 Received: September 30, 2003

Dear Mr. Zimovan:

This letter corrects our substantially equivalent letter of December 18, 2003, regarding the contact name.

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 (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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 requirements, 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. Brian S. Zimovan

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Muriam C. Provost

onCelia 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): K033161

Device Name: Visu-Loc™ 5mm Clip Applier

Indications For Use:

The Visu-Loc™ 5mm Clip Applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

Prescription Use Yes (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

Jivision Sign-Off) Division of General, Restorative and Neurological Devices

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y(k) Number K033/6/