FDA 510(k)
FDA class 2
Unknown
🇩🇪 Germany
remOVE System
K Number: DEN160014
·
Decision Dec 22, 2017
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
14
Review Days
620
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Basic Information
- Device Name
- remOVE System
- K Number
- DEN160014
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 876.4310
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Applicant
- Ovesco Endoscopy AG
- Date Received
- April 11, 2016
- Decision Date
- December 22, 2017
- Product Code
- QAG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAG | Endoscopic Electrosurgical Clip Cutting System | FDA class 2 | Obstetrics/Gynecology |
Other Clearances by Ovesco Endoscopy AG
| K Number | Device Name | ||
|---|---|---|---|
| K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Dec 18, 2025 | Substantially Equivalent |
| K242586 | ArgoCap (200.52) | May 22, 2025 | Substantially Equivalent |
| K241858 | BARS Set (100.60) | Aug 26, 2024 | Substantially Equivalent |
| K221385 | LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) | Aug 11, 2022 | Substantially Equivalent |
| K200684 | gastroduodenal FTRD Set | Jun 2, 2020 | Substantially Equivalent |
| K183309 | stentfix OTSC System Set | Oct 22, 2019 | Substantially Equivalent |
| K170867 | FTRD System Set | Jul 25, 2017 | Substantially Equivalent |
| K153550 | FTRD System Set | Oct 12, 2016 | Substantially Equivalent |
| K150067 | OTSC Proctology | Sep 16, 2015 | Substantially Equivalent |
| K141790 | AQANIFE | Mar 6, 2015 | Substantially Equivalent |