The following data is part of a premarket notification filed by Antyllos Medizintechnik Gmbh with the FDA for Endoscopic Tube Shaft Instruments For Monoplar Coagulation.
| Device ID | K010192 |
| 510k Number | K010192 |
| Device Name: | ENDOSCOPIC TUBE SHAFT INSTRUMENTS FOR MONOPLAR COAGULATION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ANTYLLOS MEDIZINTECHNIK GMBH UNTERER WINKEL 3 Wurmlingen, DE 78573 |
| Contact | Harald Jung |
| Correspondent | Harald Jung ANTYLLOS MEDIZINTECHNIK GMBH UNTERER WINKEL 3 Wurmlingen, DE 78573 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-04-02 |