POLYESTER NONABSORBABLE SURGICAL SUTURES, USP— 510(k) K000540
Substantially Equivalent for Some IndicationsArc Medical Supplies (Beijing) Co, Ltd.
FDA 510(k) clearance K000540 for POLYESTER NONABSORBABLE SURGICAL SUTURES, USP, Substantially Equivalent for Some Indications on 2000-04-27. Applicant: Arc Medical Supplies (Beijing) Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Arc Medical Supplies (Beijing) Co, Ltd.
- Product code
- Product code GAT
- Device class
- Class 2
- Regulation
- 21 CFR 878.5000
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Syosset, NY, US
Recent devices under product code GAT
view allMore clearances from Arc Medical Supplies (Beijing) Co, Ltd.
view all- K022666 — PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
- K022664 — PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
- K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP
- K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
- K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP
Adverse events under product code GAT
product code GAT- Death
- 19
- Injury
- 4,163
- Malfunction
- 8,646
- Other
- 2
- Total
- 12,830
Source: openFDA MAUDE database, through . 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.