The following data is part of a premarket notification filed by Medsys, S.a. with the FDA for Lap Loop.
| Device ID | K092897 |
| 510k Number | K092897 |
| Device Name: | LAP LOOP |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | MEDSYS, S.A. 220 RIVER RD. Claremont, NH 03743 |
| Contact | William F Greenrose |
| Correspondent | William F Greenrose MEDSYS, S.A. 220 RIVER RD. Claremont, NH 03743 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-02-01 |