Synovis Surgical Innovations, Inc.
FDA Regulatory Profile
Synovis Surgical Innovations, Inc. appears in FDA public data with 3 recalls — including 1 Class I (most serious) —, 8 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1637-2015, Class I) was initiated on May 2, 2015. Its most recent 510(k) clearance was granted on March 8, 2013.
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1637-2015 | Class I | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, produ | May 2, 2015 |
| Z-0339-2014 | Class II | Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure | October 28, 2013 |
| Z-0338-2014 | Class II | Vascu Guard, Peripheral Vascular Patch with Apex Processing. For use in peripheral vascular recon | October 28, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | March 8, 2013 |
| K083039 | VERITAS COLLAGEN MATRIX (DRY) | November 26, 2008 |
| K062915 | VERITAS COLLAGEN MATRIX | December 6, 2006 |
| K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | October 27, 2004 |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE | April 14, 2004 |
| K040119 | PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-ST | March 17, 2004 |
| K040001 | STEERABLE STYLET | March 9, 2004 |
| K030879 | VERITAS COLLAGEN MATRIX | April 24, 2003 |