FSSB NYLON SURGICAL SUTURES— 510(k) K060471

Substantially Equivalent

Fssb Chirurgische Nadeln GmbH

FDA 510(k) clearance K060471 for FSSB NYLON SURGICAL SUTURES, Substantially Equivalent on 2006-07-26. Applicant: Fssb Chirurgische Nadeln GmbH.

Clearance details

Applicant: Fssb Chirurgische Nadeln GmbH
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 2006-02-23
Decision date: 2006-07-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Washington, DC, US

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Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.