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510(k) K161065

ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator by Surgitools Pty , Ltd. — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2016
Date Received
April 15, 2016
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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  • K110819 — SINGHMED ROOLIP MANIPULATOR (October 5, 2011)
  • K051594 — MCCARTNEY ACCESS TUBE (September 2, 2005)
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