Symmetry Surgical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 5
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1011-2017 | Class II | symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136 | November 29, 2016 |
| Z-1010-2017 | Class II | symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C | November 29, 2016 |
| Z-1012-2017 | Class II | symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, | November 29, 2016 |
| Z-2316-2015 | Class II | SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel | June 16, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173272 | Ergonomic Handle | February 9, 2018 |
| K161744 | Symmetry Sharp Kerrison Rongeur | September 7, 2016 |
| K152111 | Symmetry Surgical Quad-Lock Container System | April 14, 2016 |
| K143078 | Bookwalter Gordon Adjustable Compression Element | May 14, 2015 |
| K130541 | SYMMETRY KERRISON DISPOSABLE TIP RONGEURS | August 5, 2013 |