510(k) K153513
K153513 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine GmbH for the device "Insufflator 50L FM134". The FDA issued a decision of Substantially Equivalent on March 4, 2016. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. 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 4, 2016
- Date Received
- December 7, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type