The following data is part of a premarket notification filed by Electroscope, Inc. with the FDA for Bipolar Electrosurgical Pencil, Straight And Angled.
| Device ID | K972562 |
| 510k Number | K972562 |
| Device Name: | BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ELECTROSCOPE, INC. 4828 STERLING DR. Boulder, CO 80301 |
| Contact | Jane E Johnson |
| Correspondent | Jane E Johnson ELECTROSCOPE, INC. 4828 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 | 1997-07-09 |
| Decision Date | 1998-01-16 |