SILK Surgical Suture— 510(k) K162396

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K162396 for SILK Surgical Suture, Substantially Equivalent on 2016-11-23. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code GAP
Advisory panel: General, Plastic Surgery
Date received: 2016-08-26
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAP

product code GAP

Death: 3
Injury: 491
Malfunction: 2,253
Total: 2,747

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.