Surgical Stainless Steel Suture, Stainless Steel Suture— 510(k) K170767

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K170767 for Surgical Stainless Steel Suture, Stainless Steel Suture, Substantially Equivalent on 2017-11-01. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code GAQ
Advisory panel: General, Plastic Surgery
Date received: 2017-03-14
Decision date: 2017-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.