Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only. This page is not medical advice and does not describe how to use any device on a patient.
Short answer
Hemostasis clips are small implantable clips, made of metal or polymer, that are placed on a vessel or tissue to stop bleeding or close it off. In the United States, FDA regulates the clip as a class II implant under 21 CFR 878.4300, while the instrument that carries the clip, the clip applier, is a class I manual instrument under 21 CFR 878.4800.
Definition and scope
FDA’s regulation 21 CFR 878.4300 defines an implantable clip as “a clip-like device intended to connect internal tissues to aid healing” that is not absorbable, and classifies it as class II (Cornell Legal Information Institute copy of the CFR, checked 2026-10-30). Trade and clinical names for the same device family include hemostatic clip, ligating clip, ligation clip and surgical clip. This page covers clips used to close or ligate vessels and tissue. It does not cover the removable skin clips used on a wound surface, which FDA lists under a different regulation (see misunderstandings below).
How clips are used in practice
The regulation text frames a clip as a device that connects internal tissues, and Teleflex describes its polymer ligating clips as inert, nonconductive and radiolucent. A clip is delivered by a separate applier. FDA’s general-use instrument regulation, 21 CFR 878.4800, names the clip applier among nonpowered, hand-held, reusable or disposable surgical instruments. Teleflex’s Weck polymer ligation page (checked 2026-10-30) lists its Hem-o-lok ligating clips in Medium, Medium-Large, Large and Extra-Large sizes and states they ligate structures from 2 mm to 16 mm. Sizing varies by manufacturer and product line, and each product’s instructions for use state the vessel or tissue range it is labeled for.
Types and related terms
Hem-o-lok clips
Hem-o-lok is Teleflex’s brand of nonabsorbable polymer ligating clips. FDA’s 510(k) database shows the family clearing under product code FZP, “Clip, Implantable”, from K982941 (Weck Closure Systems, cleared 1998-11-19) through K133202 (Teleflex, 2013-12-03) to K251054, Hem-o-lok PurplePlus Large Polymer Ligating Clips (Teleflex, 2025-07-03), each with a Substantially Equivalent decision (openFDA, checked 2026-10-30).
Suture clip and ligation clip
“Suture clip” is used loosely in catalogs. Internal ligation clips fall under the product codes in the table below. A different device, the removable skin clip (product code FZQ, 21 CFR 878.4320), is class I and is not an implantable clip.
Ligaclip and titanium clips
Metal hemostatic clips clear under the same classification, for example K972745 (Titanium Hemostatic Clip, Eisner, 1997) and K040148 (Resolution hemostasis clipping device, Boston Scientific, 2004) under product code MCH (openFDA 510(k), checked 2026-10-30). Clip sizes are set by each manufacturer’s product line and stated in its instructions for use.
| FDA product code | Name in FDA database | Class | Regulation |
|---|---|---|---|
| MCH | Clip, Hemostatic | II | 21 CFR 878.4300 |
| FZP | Clip, Implantable | II | 21 CFR 878.4300 |
| NMJ | Clip, Implantable, Reprocessed | II | 21 CFR 878.4300 |
| HBT | Applier, Hemostatic Clip | I | 21 CFR 878.4800 |
| GDO | Applier, Surgical, Clip | I | 21 CFR 878.4800 |
Source: openFDA device classification API (https://api.fda.gov/device/classification.json), checked 2026-10-30. Other implantable clips share the same regulation, including vas deferens (NJC), coronary artery bypass graft (NCA) and left atrial appendage (PZX) clips.
Clip versus applier: why they are regulated differently
The table shows the split. The clip stays in the body, so it is a class II implant. The applier is a hand instrument, so it is class I. For a procurement or regulatory file, a clip and its applier are separate items with separate product codes, and a reprocessed clip has its own code (NMJ). FDA’s definition for NMJ states that reprocessing validation data must be included in a 510(k).
Where it matters for labs, clinics and supply decisions
Staff who record or review these items can use the product code to place an item: MCH or FZP for a new clip, NMJ for a reprocessed clip, HBT or GDO for an applier. Labeling also changes after incidents. FDA’s recall database records a Class 2 recall of Weck Hem-o-lok ML polymer ligating clips by Teleflex Medical (initiated 2006-04-12, terminated 2007-11-14; 3,656,100 medium-large clips in that record). The reason given was that clips may become dislodged after ligation of the renal artery in laparoscopic donor nephrectomy, and the instructions for use were updated to contraindicate the clips for ligating the renal artery in that procedure. The lesson for supply staff is to read the current instructions for use for each clip family rather than rely on a catalog description. For related instruments see laparoscopic instruments, neurosurgical instruments (which include aneurysm clip appliers) and the electrosurgical unit guide, which contrasts vessel sealing with ties and clips. The wider device framework is in what is a medical device and medical device reporting.
Common misunderstandings
- Clip and applier are one regulated item. They are not: a class II implant versus a class I manual instrument.
- A suture clip is a hemostasis clip. The removable skin clip (FZQ) is a different, class I device.
- Clips are interchangeable across brands. Each product has its own cleared indications and instructions for use, and the 2006 recall shows labeling can change.
FAQ
What are hemostasis clips?
Implantable, nonabsorbable clips used to close off vessels or connect internal tissue; FDA classifies them as class II under 21 CFR 878.4300.
What are Hem-o-lok clips?
A Teleflex brand of nonabsorbable polymer ligating clips, cleared under product code FZP since 1998.
Are clip appliers regulated like clips?
No. Clip appliers (HBT, GDO) are class I manual instruments under 21 CFR 878.4800.
Sources
- 21 CFR 878.4300, Implantable clip: https://www.law.cornell.edu/cfr/text/21/878.4300 (checked 2026-10-30)
- 21 CFR 878.4800, Manual surgical instrument for general use: https://www.law.cornell.edu/cfr/text/21/878.4800 (checked 2026-10-30)
- openFDA device classification and 510(k) APIs: https://api.fda.gov/device/classification.json and https://api.fda.gov/device/510k.json (checked 2026-10-30)
- FDA recall database record 45799 (Weck Hem-o-lok ML clips): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45799 (checked 2026-10-30)
- Teleflex Weck polymer ligation: https://www.teleflex.com/usa/en/product-areas/surgical/ligation-solutions/weck-polymer-ligation/ (checked 2026-10-30)
