The following data is part of a premarket notification filed by Everest Medical Corp. with the FDA for Monopolar Sphinctertome.
| Device ID | K911787 |
| 510k Number | K911787 |
| Device Name: | MONOPOLAR SPHINCTERTOME |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Contact | Joseph A O'brien |
| Correspondent | Joseph A O'brien EVEREST MEDICAL CORP. 13755 FIRST AVENUE NORTH Minneapolis, MN 55441 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-07-19 |