HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS

K982313 · Weck Closure Systems · FZP · Aug 10, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K982313
• Device Name: HORIZON TITANIUM CLIPS, HORIZON TANTALUM CLIPS
• Applicant: Weck Closure Systems
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Aug 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where Horizon ligating this are the best clip size, type and material based upon experience, judgement and needs.

Device Story

Horizon Ligation Clips are surgical implants used for vessel or anatomic structure ligation. The device is applied by a surgeon during surgical procedures to occlude vessels or tissues. The clips are selected based on clinician experience and judgment regarding size, type, and material requirements for the specific anatomical site. The device functions as a mechanical fastener to provide hemostasis or tissue closure. It is intended for use in clinical/surgical settings.

Technological Characteristics

Mechanical ligation clips; material composition and dimensions determined by clinical application requirements.

Indications for Use

Indicated for use in surgical procedures involving ligation of vessels or anatomic structures where the clinician determines the clip size, type, and material are appropriate based on professional judgment and patient needs.

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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 1998

Mr. Brian J. Young Requlatory Affairs Manaqer Weck Closure Systems One Weck Drive P.O. Box 12600 27709 Research Triangle Park, North Carolina

K982313 Re: Trade Name: Horizon Ligation Clips Regulatory Class: II Product Code: FZP Dated: June 30, 1998 Received: July 1, 1998

Dear Mr. Young:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Brian J. Young

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colvin M. Whitten, Ph.D., M.

- Celya M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 2 Statement of indications for use

## INDICATIONS FOR USE

## INDICATIONS FOR USE

Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.

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(Division)Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number __