510(k) K935023

GODAT UTERINE MANIPULATOR INJECTOR by Ideas For Medicine, Inc. — Product Code LKF

K935023 is an FDA 510(k) premarket notification submitted by Ideas For Medicine, Inc. for the device "GODAT UTERINE MANIPULATOR INJECTOR". The FDA issued a decision of Substantially Equivalent on January 4, 1995. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Ideas For Medicine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1995
Date Received
October 20, 1993
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