remOVE System
FDA 510(k) clearance DEN160014 · decided 2017-12-22
Clearance details
- K-number
- DEN160014
- Device name
- remOVE System
- Applicant
- Ovesco Endoscopy AG
- Decision
- Unknown
- Date received
- 2016-04-11
- Decision date
- 2017-12-22
- Days to decision
- 620 days
- Clearance type
- Direct
- Product code
- QAG
- Device class
- 2
- Regulation number
- 876.4310
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Tuebingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.