The following data is part of a premarket notification filed by Electroscope, Inc. with the FDA for Monopolar Laparoscopic Electrodes W/eletroshield.
| Device ID | K912780 |
| 510k Number | K912780 |
| Device Name: | MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELECTROSCOPE, INC. 4890 STERLING DR. Boulder, CO 80301 |
| Contact | Roger C.odell |
| Correspondent | Roger C.odell ELECTROSCOPE, INC. 4890 STERLING DR. Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-24 |
| Decision Date | 1991-12-30 |