# K991500: Smith & Nephew Suture Lok

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Jul 14, 1999 after 76 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 Collet: named in the summary without a submission number
- (no number) Suture Lock: named in the summary without a submission number
- (no number) braided silk, nylon or polyester 0, 2-0, and 3-0 suture: named in the summary without a submission number

## Most influential descendants
- K000717: Smith & Nephew Suturelok, Model 7207321 (2000), 0 descendants of its own

## Indications for use
The Smith & Nephew Suture Lok is indicated for use in open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures and general surgery. The device is not indicated for use in contraception tubal ligation.

Source page: https://510kreport.com/device/K991500
Methodology: https://510kreport.com/methodology