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De Novo DEN160014
- Device
- remOVE System
- Contact
- med.marc o. schurr
- De Novo number
- DEN160014
- Product code
- QAG
- Regulation
- 876.4310
- Classification name
- endoscopic electrosurgical clip cutting system
- Decision
- granted (DENG)
- Decision date
- 2017-12-22
- Date received
- 2016-04-11
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QAG
- Device name
- Endoscopic Electrosurgical Clip Cutting System
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 876.4310
- Implant
- N
- Life sustain/support
- N