The following data is part of a premarket notification filed by Sutter Medizintechnik Gmbh with the FDA for Sutter Bipolar Forceps - Supergliss.
| Device ID | K131012 |
| 510k Number | K131012 |
| Device Name: | SUTTER BIPOLAR FORCEPS - SUPERGLISS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SUTTER MEDIZINTECHNIK GMBH TULLASTRASSE 87 Freiburg, DE D-79108 |
| Contact | Sabine Klugbauer |
| Correspondent | Sabine Klugbauer SUTTER MEDIZINTECHNIK GMBH TULLASTRASSE 87 Freiburg, DE D-79108 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-11 |
| Decision Date | 2013-08-23 |
| Summary: | summary |