STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device— 510(k) K151200
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K151200 for STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device, Substantially Equivalent on 2015-08-13. Applicant: ETHICON, Inc..
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code GAM
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
Adverse events under product code GAM
product code GAM- Death
- 45
- Injury
- 5,711
- Malfunction
- 30,744
- Other
- 4
- Total
- 36,504
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.