Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture— 510(k) K151165

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K151165 for Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture, Substantially Equivalent on 2016-02-17. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 2015-05-01
Decision date: 2016-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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.