The following data is part of a premarket notification filed by Getsch+hiller Medizintechnik Gmbh with the FDA for Monopolar Single Use Laparoscopic Instrument.
| Device ID | K171523 |
| 510k Number | K171523 |
| Device Name: | Monopolar Single Use Laparoscopic Instrument |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Getsch+Hiller Medizintechnik GmbH Sattlerstr.20 Tuttlingen, DE 78532 |
| Contact | Werner Hiller |
| Correspondent | Werner Hiller Getsch+Hiller Medizintechnik GmbH Sattlerstr.20 Tuttlingen, DE 78532 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-25 |
| Decision Date | 2017-08-22 |
| Summary: | summary |