Skip to contentDe Novo DEN130040
- Device
- IOGYN SYSTEM
- Contact
- mary edwards
- De Novo number
- DEN130040
- Product code
- PGT
- Regulation
- 884.1710
- Classification name
- insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
- Decision
- granted (DENG)
- Decision date
- 2014-03-28
- Date received
- 2013-08-30
- Classification advisory
- Obstetrics/Gynecology
- Review advisory
- Obstetrics/Gynecology
- Type
- Direct
Current FDA Classification#
- Product code
- PGT
- Device name
- Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation
- 884.1710
- Implant
- N
- Life sustain/support
- N