ORLON NONABSORABLE SURGICAL SUTURE USP— 510(k) K030177

Substantially Equivalent

Sri Orion Pharmaceuticals & Sutures

FDA 510(k) clearance K030177 for ORLON NONABSORABLE SURGICAL SUTURE USP, Substantially Equivalent on 2003-07-21. Applicant: Sri Orion Pharmaceuticals & Sutures.

Clearance details

Applicant: Sri Orion Pharmaceuticals & Sutures
Product code: Code GAR
Advisory panel: General, Plastic Surgery
Date received: 2003-01-17
Decision date: 2003-07-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Potomac, MD, 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.