510(k) K022449
K022449 is an FDA 510(k) premarket notification submitted by W.O.M. World of Medicine AG for the device "HYSTEREOSCOPY PUMP HM4". The FDA issued a decision of Substantially Equivalent on April 10, 2003. 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 AG has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 2003
- Date Received
- July 26, 2002
- 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