510(k) K123258
K123258 is an FDA 510(k) premarket notification submitted by Catheter Research, Inc. for the device "THE ADVANCE CATHETER FOR HSG AND SIS". The FDA issued a decision of Substantially Equivalent on January 31, 2013. 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
- January 31, 2013
- Date Received
- October 18, 2012
- Clearance Type
- Special
- 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