PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.— 510(k) K022666

Name: FDA 510(k) clearance K022666
Creator: U.S. Food and Drug Administration
Published: 2002-10-09

Substantially Equivalent

Arc Medical Supplies (Beijing) Co, Ltd.

FDA 510(k) clearance K022666 for PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P., Substantially Equivalent on 2002-10-09. Applicant: Arc Medical Supplies (Beijing) Co, Ltd.. Device class: 2.

Clearance details

Applicant: Arc Medical Supplies (Beijing) Co, Ltd.
Product code: Product code NEW
Device class: Class 2
Regulation: 21 CFR 878.4840
Advisory panel: General, Plastic Surgery
Date received: 2002-08-09
Decision date: 2002-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Berlin, WI, US

Download summary PDF View on FDA.gov ↗

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K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP2000-04-28
K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP2000-04-28
K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP2000-04-27
K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP2000-04-27

Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

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.