The following data is part of a premarket notification filed by Gunter Bissinger Medizintechnik Gmbh with the FDA for Powergrip Bipolar Coagulation Forceps, Model 824xxxxx.
| Device ID | K033177 |
| 510k Number | K033177 |
| Device Name: | POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | GUNTER BISSINGER MEDIZINTECHNIK GMBH AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Contact | Dagmar Maser |
| Correspondent | Dagmar Maser GUNTER BISSINGER MEDIZINTECHNIK GMBH AMSTEL 320-I Amsterdam, NL 1017 Ap |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-01 |
| Decision Date | 2004-03-11 |
| Summary: | summary |