510(k) K163320
K163320 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine GmbH for the device "LAP-Pump PP110". The FDA issued a decision of Substantially Equivalent on March 21, 2017. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. 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 21, 2017
- Date Received
- November 23, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type