HEM-O-LOK LIGATION CLIP

K062914 · Teleflex Medical · FZP · Nov 2, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K062914
• Device Name: HEM-O-LOK LIGATION CLIP
• Applicant: Teleflex Medical
• Product Code: FZP · General, Plastic Surgery
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hem-o-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Device Story

Hem-o-Lok® ligating clips are non-absorbable, acetyl polymer clips used for hemostasis during surgical procedures. The device is manually applied by a surgeon to ligate vessels or tissue structures. The surgeon selects the appropriate clip size to ensure complete encompassment of the target vessel or tissue. The clip acts as a mechanical fastener to connect internal tissues and aid healing. It is used in clinical settings by surgeons.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-absorbable acetyl polymer ligating clips. Available in various sizes. Manually applied. Mechanical ligation principle.

Indications for Use

Indicated for use in surgical procedures requiring ligation of vessels or tissue structures. Intended for use by surgeons to ligate vessels or tissue structures by selecting a clip size that completely encompasses the target structure.

Regulatory Classification

Identification

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

Predicate Devices

• Weck Hemo-Lok® clips (K982941)
• Weck Hemo-Lok® clips (K993157)
• Weck Hemo-Lok® clips (K003337)
• Weck Hemo-Lok® clips (K030311)
• Hem-o-Lok® ML Automatic Endoscopic Applier (K021808)

Submission Summary (Full Text)

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K063914

Image /page/0/Picture/1 description: The image shows the logo for Teleflex Medical. The word "Teleflex" is in a bold, sans-serif font, with a stylized "T" that resembles a bent tube. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.

Teleflex Medical Group Headquarters 2345 Waukegan Road Bannockburn, II. 60015 USA Phone: [phone] Fax: [phone] www.teleflex.com

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Hem-o-Lok® Ligating Clips

# A. Name, Address, Phone and Fax Number of Applicant

Telefiex Medical 2345 Waukegan Road Suite 120 Bannockburn, IL 60015

NOV - 2 2006

### B. Contact Person

Lori Hays Senior Manager Regulatory Affairs

#### C. Date Prepared

September 21, 2006

### D. Device Name

Trade Name: Hem-o-Lok® Ligating Clip Common Name: Ligating Clip Classification Name: Implantable Clip Product Code: FZP Regulation Number: 21 CFR 878.4300 Class: Il

### E. Device Description

The Weck Hem-o-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. The clips are intended for use in procedures involving ligation of vessels or tissue structures.

The Hem-o-Lok® clips are made from a non-absorbable acetyl polymer and are available in various sizes. Surgeons select the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

#### F. Intended Use

Hem-o-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

#### G. Substantial Equivalence

The Weck Hem-o-Lok® ligating clips are substantially equivalent to the The Weck Hemo-Lok® clips previously cleared under 510(k)s: K982941, K993157, K003337, K030311. and the Hem-o-Lok® ML Automatic Endoscopic Applier cleared under 510(k) K021808.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a series of flowing lines. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Teleflex Medical Group % Ms. Lori Hays, MT, RAC Senior Manager, Regulatory Affairs 2345 Waukegan Road Bannockbun, Illinois 60015

NOV - 2 2006

Re: K062914

Trade/Device Name: Hem-o-Lok® Ligating Clip Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: FZP Dated: September 21, 2006 Received: September 27, 2006

Dear Ms. Hays:

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 application (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 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 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 - Ms. Lori Hays, MT, RAC

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K028314

### Indications for Use

510(k) Number (if known):

Device Name: Hem-o-Lok® Ligating Clip

Indications For Use:

Hem-o-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessels or tissue structure to be ligated such the clip completely encompasses the vessel or tissue structure

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(**Division Sign-Off**)
Division of General, Restorativo

and Neurological Devices

**510(k) Number** L022914