← Product Code [FZP](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP) · K062914 # HEM-O-LOK LIGATION CLIP (K062914) _Teleflex Medical · FZP · Nov 2, 2006 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K062914 ## Device Facts - **Applicant:** Teleflex Medical - **Product Code:** [FZP](/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP.md) - **Decision Date:** Nov 2, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4300 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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](/device/K982941.md)) - Weck Hemo-Lok® clips ([K993157](/device/K993157.md)) - Weck Hemo-Lok® clips ([K003337](/device/K003337.md)) - Weck Hemo-Lok® clips ([K030311](/device/K030311.md)) - Hem-o-Lok® ML Automatic Endoscopic Applier ([K021808](/device/K021808.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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: 847-572-8002 Fax: 847-572-8001 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 (240) 276-0115. 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 (240) 276-3150 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 {3}------------------------------------------------ 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) Page 1 of *1* (**Division Sign-Off**) Division of General, Restorativo and Neurological Devices **510(k) Number** L022914 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K062914](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FZP/K062914) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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