SILK NONABSORBABLE SURGICAL SUTURES USP— 510(k) K960328
Substantially Equivalent for Some IndicationsR. K. Medical L. L. C.
FDA 510(k) clearance K960328 for SILK NONABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent for Some Indications on 1996-03-04. Applicant: R. K. Medical L. L. C..
Clearance details
- Applicant
- R. K. Medical L. L. C.
- Product code
- Code GAP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Mahwah, NJ, 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.