STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device— 510(k) K253572
Substantially EquivalentETHICON, Inc.
FDA 510(k) clearance K253572 for STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device, Substantially Equivalent on 2026-03-27. Applicant: ETHICON, Inc..
Clearance details
- Applicant
- ETHICON, Inc.
- Product code
- Code GAW
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raritan, 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.