POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP— 510(k) K000537
Substantially Equivalent for Some IndicationsArc Medical Supplies (Beijing) Co, Ltd.
FDA 510(k) clearance K000537 for POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP, Substantially Equivalent for Some Indications on 2000-04-27. Applicant: Arc Medical Supplies (Beijing) Co, Ltd..
Clearance details
- Applicant
- Arc Medical Supplies (Beijing) Co, Ltd.
- Product code
- Code GAW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Syosset, NY, US
Adverse events under product code GAW
product code GAW- Death
- 66
- Injury
- 1,616
- Malfunction
- 10,428
- Total
- 12,110
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.