SMITH & NEPHEW SUTURE LOK— 510(k) K991500

Substantially Equivalent

Smith & Nephew Endoscopy, Inc.

FDA 510(k) clearance K991500 for SMITH & NEPHEW SUTURE LOK, Substantially Equivalent on 1999-07-14. Applicant: Smith & Nephew Endoscopy, Inc..

Clearance details

Applicant: Smith & Nephew Endoscopy, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-29
Decision date: 1999-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.