510(k) K132423
K132423 is an FDA 510(k) premarket notification submitted by Gynius AB for the device "THE GYNOCULAR". The FDA issued a decision of Substantially Equivalent on April 8, 2014. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2014
- Date Received
- August 5, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colposcope (And Colpomicroscope)
- Device Class
- Class II
- Regulation Number
- 884.1630
- Review Panel
- OB
- Submission Type