AQANIFE
Electrosurgical, Cutting & Coagulation & Accessories
OVESCO ENDOSCOPY AG
The following data is part of a premarket notification filed by Ovesco Endoscopy Ag with the FDA for Aqanife.
Pre-market Notification Details
| Device ID | K141790 |
| 510k Number | K141790 |
| Device Name: | AQANIFE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, Baden-wuerttemberg, DE 72074 |
| Contact | Tanja R Linzer |
| Correspondent | Tanja R Linzer OVESCO ENDOSCOPY AG DORFACKERSTRASSE 26 Tuebingen, Baden-wuerttemberg, DE 72074 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2015-03-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260206310419 | K141790 | 000 |
| 04260206310402 | K141790 | 000 |
| 04260206310396 | K141790 | 000 |
| 04260206310389 | K141790 | 000 |
Trademark Results [AQANIFE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQANIFE 85602449 4363250 Live/Registered |
Ovesco Endoscopy AG 2012-04-19 |
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