The following data is part of a premarket notification filed by A.m. Surgical, Inc. with the FDA for Mountable Endoscopic Knife.
| Device ID | K982142 |
| 510k Number | K982142 |
| Device Name: | MOUNTABLE ENDOSCOPIC KNIFE |
| Classification | Knife, Surgical |
| Applicant | A.M. SURGICAL, INC. 290 EAST MAIN ST. SUITE 200 Smithtown, NY 11787 |
| Contact | Eugene T King |
| Correspondent | Eugene T King A.M. SURGICAL, INC. 290 EAST MAIN ST. SUITE 200 Smithtown, NY 11787 |
| Product Code | EMF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-17 |
| Decision Date | 1998-12-30 |