POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES— 510(k) K961389
Substantially Equivalent for Some IndicationsR. K. Medical L. L. C.
FDA 510(k) clearance K961389 for POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, Substantially Equivalent for Some Indications on 1996-06-18. Applicant: R. K. Medical L. L. C..
Clearance details
- Applicant
- R. K. Medical L. L. C.
- Product code
- Code GAW
- 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 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.