# K971939: Smith & Nephew Suture Collet

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Aug 6, 1997 after 71 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Suture Lock: named in the summary without a submission number
- (no number) silk 2-0 suture: named in the summary without a submission number

## Indications for use
The Smith & Nephew Suture Collet is indicated for use in the management of soft vessel ligation and / or fixation of soft tissue structures during open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures, and general surgery. The device is not indicated for use in contraceptive tubal ligation.

Source page: https://510kreport.com/device/K971939
Methodology: https://510kreport.com/methodology