510(k) K131781

CLEARVIEW TOTAL by Clinical Innovations, LLC — Product Code LKF

K131781 is an FDA 510(k) premarket notification submitted by Clinical Innovations, LLC for the device "CLEARVIEW TOTAL". The FDA issued a decision of Substantially Equivalent on May 28, 2014. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Clinical Innovations, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2014
Date Received
June 17, 2013
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