POLYESTER NONABSORBABLE SURGICAL SUTURES USP— 510(k) K961925
Substantially Equivalent for Some IndicationsR. K. Medical L. L. C.
FDA 510(k) clearance K961925 for POLYESTER NONABSORBABLE SURGICAL SUTURES USP, Substantially Equivalent for Some Indications on 1996-07-29. Applicant: R. K. Medical L. L. C..
Clearance details
- Applicant
- R. K. Medical L. L. C.
- Product code
- Code GAT
- 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 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.