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510(k) K110819

SINGHMED ROOLIP MANIPULATOR by J.Singh Instruments — Product Code HEW

K110819 is an FDA 510(k) premarket notification submitted by J.Singh Instruments for the device "SINGHMED ROOLIP MANIPULATOR". The FDA issued a decision of Substantially Equivalent on October 5, 2011. The device falls under product code HEW (Culdoscope (And Accessories)), a Class II device regulated under 21 CFR 884.1640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2011
Date Received
March 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culdoscope (And Accessories)
Device Class
Class II
Regulation Number
884.1640
Review Panel
OB
Submission Type

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  • K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (July 13, 2012)
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FDA data resources