The following data is part of a premarket notification filed by Surgical Innovations Plc with the FDA for Pretzelflex Surgical Retractor Model Shr7301.
| Device ID | K123110 |
| 510k Number | K123110 |
| Device Name: | PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGICAL INNOVATIONS PLC CLAYTON WOOD HOUSE, 6 CLAYTON WOOD BANK Leeds, West Yorkshire, GB Ls16 6zq |
| Contact | Tracey Fearnley |
| Correspondent | Tracey Fearnley SURGICAL INNOVATIONS PLC CLAYTON WOOD HOUSE, 6 CLAYTON WOOD BANK Leeds, West Yorkshire, GB Ls16 6zq |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-03 |
| Decision Date | 2013-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051986009667 | K123110 | 000 |
| 05051986008561 | K123110 | 000 |
| 05051986009759 | K123110 | 000 |
| 05051986009742 | K123110 | 000 |
| 10885403199257 | K123110 | 000 |
| 10885403199264 | K123110 | 000 |