510(k) K974801
K974801 is an FDA 510(k) premarket notification submitted by Conkin Surgical Instruments , Ltd. for the device "SINGLE CHANNEL BALLOON CANNULA". The FDA issued a decision of Substantially Equivalent on Jul 9, 1998. The device falls under product code HDP (Elevator, Uterine), a Class II device regulated under 21 CFR 884.4530.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 9, 1998
- Date Received
- Dec 22, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Elevator, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
- 510(k)