510(k) K974357
K974357 is an FDA 510(k) premarket notification submitted by Catheter Research, Inc. for the device "UTERINE MANIPULATOR/INJECTOR". The FDA issued a decision of Substantially Equivalent on February 2, 1998. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Catheter Research, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 2, 1998
- Date Received
- November 19, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Manipulator/Injector, Uterine
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type