STAINLESS 22-13-5 SUTURE WIRE— 510(k) K873645

Name: FDA 510(k) clearance K873645
Creator: U.S. Food and Drug Administration
Published: 1987-11-17

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K873645 for STAINLESS 22-13-5 SUTURE WIRE, Substantially Equivalent on 1987-11-17. Applicant: Zimmer, Inc.. Device class: 2.

Clearance details

Applicant: Zimmer, Inc.
Product code: Product code GAQ
Device class: Class 2
Regulation: 21 CFR 878.4495
Advisory panel: General, Plastic Surgery
Date received: 1987-09-08
Decision date: 1987-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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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.