The following data is part of a premarket notification filed by Guenter Bissinger Medizintechnik Gmbh with the FDA for Supra Non-stick Bipolar Forceps.
| Device ID | K213042 |
| 510k Number | K213042 |
| Device Name: | Supra Non-Stick Bipolar Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Guenter Bissinger Medizintechnik GmbH Hans-Theisen-Str. 1 Teningen, DE 79331 |
| Contact | Matthias Bissinger |
| Correspondent | Matthias Bissinger Guenter Bissinger Medizintechnik GmbH Hans-Theisen-Str. 1 Teningen, DE 79331 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-22 |
| Decision Date | 2022-11-17 |