DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE— 510(k) K990090

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K990090 for DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE, Substantially Equivalent on 1999-03-22. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 1999-01-11
Decision date: 1999-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.