The following data is part of a premarket notification filed by Surgical Innovations Group Plc with the FDA for Fastclamp Endoscopic Clamping System.
| Device ID | K100442 |
| 510k Number | K100442 |
| Device Name: | FASTCLAMP ENDOSCOPIC CLAMPING SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SURGICAL INNOVATIONS GROUP PLC CLAYTON WOOD HOUSE 6 CLAYTON WOOD BANK Leeds West Yorkshire, GB Ls16,6qz |
| Contact | Mike White |
| Correspondent | Mike White SURGICAL INNOVATIONS GROUP PLC CLAYTON WOOD HOUSE 6 CLAYTON WOOD BANK Leeds West Yorkshire, GB Ls16,6qz |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051986011622 | K100442 | 000 |
| 05051986006628 | K100442 | 000 |
| 05051986011547 | K100442 | 000 |
| 05051986006574 | K100442 | 000 |
| 05051986001210 | K100442 | 000 |
| 10885403156861 | K100442 | 000 |
| 10885403173769 | K100442 | 000 |
| 10885403156908 | K100442 | 000 |
| 10885403156892 | K100442 | 000 |
| 05051986011578 | K100442 | 000 |
| 05051986006581 | K100442 | 000 |
| 05051986011615 | K100442 | 000 |
| 05051986011608 | K100442 | 000 |
| 05051986011592 | K100442 | 000 |
| 05051986011585 | K100442 | 000 |
| 05051986011561 | K100442 | 000 |
| 05051986011530 | K100442 | 000 |
| 05051986006642 | K100442 | 000 |
| 05051986006635 | K100442 | 000 |
| 10885403156885 | K100442 | 000 |