SURGILENE(R) SUTURES— 510(k) K945701
Substantially Equivalent for Some IndicationsDavis & Geck, Inc.
FDA 510(k) clearance K945701 for SURGILENE(R) SUTURES, Substantially Equivalent for Some Indications on 1995-01-24. Applicant: Davis & Geck, Inc..
Clearance details
- Applicant
- Davis & Geck, Inc.
- Product code
- Code GAW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Danbury, CT, 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.