The following data is part of a premarket notification filed by Surgical Innovations Corp. with the FDA for Surgical Innovations Disposable Endoscopic Hernia Surgical Stapler Surgical Innovations Resuable Surgical Stapler Handle.
| Device ID | K944292 |
| 510k Number | K944292 |
| Device Name: | SURGICAL INNOVATIONS DISPOSABLE ENDOSCOPIC HERNIA SURGICAL STAPLER SURGICAL INNOVATIONS RESUABLE SURGICAL STAPLER HANDLE |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont, NH 03743 |
| Contact | Michele Motsiff |
| Correspondent | Michele Motsiff SURGICAL INNOVATIONS CORP. 6 PHEASANT LN. Claremont, NH 03743 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-11-15 |