510(k) K133799
K133799 is an FDA 510(k) premarket notification submitted by Thermedx, LLC for the device "THERMEDX FLUID MANAGMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 2014. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Thermedx, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2014
- Date Received
- December 13, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Hysteroscopic
- Device Class
- Class II
- Regulation Number
- 884.1700
- Review Panel
- OB
- Submission Type