FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES— 510(k) K092533
Substantially EquivalentBeere Precision Medical Instruments, Kmedic, Telef
FDA 510(k) clearance K092533 for FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES, Substantially Equivalent on 2009-09-15. Applicant: Beere Precision Medical Instruments, Kmedic, Telef.
Clearance details
- Applicant
- Beere Precision Medical Instruments, Kmedic, Telef
- Product code
- Code GAT
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Kenosha, WI, 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.