510(k) DEN130040
DEN130040 is an FDA 510(k) premarket notification submitted by Iogyn, Inc. for the device "IOGYN SYSTEM". The FDA issued a decision of De Novo Granted on March 28, 2014. The device falls under product code PGT (Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar), a Class II device regulated under 21 CFR 884.1710. Iogyn, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 28, 2014
- Date Received
- August 30, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
- Device Class
- Class II
- Regulation Number
- 884.1710
- Review Panel
- OB
- Submission Type
to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue.