510(k) K110852
K110852 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "DOLPHIN 3 FLUID MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 19, 2011. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 2011
- Date Received
- March 28, 2011
- 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