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510(k) K161065

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

K161065 is an FDA 510(k) premarket notification submitted by Surgitools Pty , Ltd. for the device "ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator". The FDA issued a decision of Substantially Equivalent on October 27, 2016. 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 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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  • K201086 — Advincula Delineator Uterine Manipulator (May 21, 2020)
  • K191294 — Transvaginal Access Platform (September 6, 2019)
  • K180429 — Advincula Delineator Uterine Manipulator (March 14, 2018)
  • K143308 — GelPOINT Transvaginal Access Platform (October 13, 2015)
  • K143650 — CooperSurgical Advincula Delineator Uterine Manipulator (July 21, 2015)
  • K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (July 13, 2012)
  • K110819 — SINGHMED ROOLIP MANIPULATOR (October 5, 2011)
  • K051594 — MCCARTNEY ACCESS TUBE (September 2, 2005)
  • K051160 — MANIPUSEAL (September 2, 2005)

FDA data resources