SILK NONABSORBABLE SURGICAL SUTURES, USP— 510(k) K000541
Substantially EquivalentArc Medical Supplies (Beijing) Co, Ltd.
FDA 510(k) clearance K000541 for SILK NONABSORBABLE SURGICAL SUTURES, USP, Substantially Equivalent on 2000-04-28. Applicant: Arc Medical Supplies (Beijing) Co, Ltd..
Clearance details
- Applicant
- Arc Medical Supplies (Beijing) Co, Ltd.
- Product code
- Code GAP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Syosset, NY, US
Adverse events under product code GAP
product code GAP- Death
- 3
- Injury
- 491
- Malfunction
- 2,253
- Total
- 2,747
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.