510(k) K173489
K173489 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine GmbH for the device "GYN-Pump PH304". The FDA issued a decision of Substantially Equivalent on March 28, 2018. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. W.O.M. World of Medicine GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2018
- Date Received
- November 13, 2017
- 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