(90 days)
Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should match clip size to the size of the vessel or tissue structure to be ligated.
Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal. The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10 . The blister packs are fitted into an overpack carton which serves as the sales unit.
This document is a 510(k) Premarket Notification for the Hem-O-Lok® Ligation Clips. It states that the device is substantially equivalent to a previously cleared device (K941972) and details its intended use and technological characteristics. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information from the provided text. The document is primarily a notification to the FDA for market clearance, focusing on substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.