PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT— 510(k) K040415
Substantially EquivalentSynovis Surgical Innovations
FDA 510(k) clearance K040415 for PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT, Substantially Equivalent on 2004-04-14. Applicant: Synovis Surgical Innovations.
Clearance details
- Applicant
- Synovis Surgical Innovations
- Product code
- Code DXZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Adverse events under product code DXZ
product code DXZ- Death
- 19
- Injury
- 265
- Total
- 284
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.