ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE— 510(k) K931271

Substantially Equivalent

ETHICON, Inc.

FDA 510(k) clearance K931271 for ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE, Substantially Equivalent on 1994-01-07. Applicant: ETHICON, Inc..

Clearance details

Applicant: ETHICON, Inc.
Product code: Code GAQ
Advisory panel: General, Plastic Surgery
Date received: 1993-03-08
Decision date: 1994-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

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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.