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510(k) K180429

Advincula Delineator Uterine Manipulator by CooperSurgical, Inc. — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2018
Date Received
February 16, 2018
Clearance Type
Special
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

Other clearances by CooperSurgical, Inc.

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  • K250438 — CooperSurgical Milex® Pessaries (April 11, 2025)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
  • K201086 — Advincula Delineator Uterine Manipulator (May 21, 2020)
  • K200038 — Endosee System (February 5, 2020)
  • K191020 — G210 InviCell Plus with SignipHy pH monitoring (January 14, 2020)
  • K191291 — Wallace Dual Lumen Oocyte Recovery System (June 12, 2019)
  • K190639 — Endosee System (May 15, 2019)
  • K182959 — Wallace Dual Lumen Oocyte Recovery System (May 10, 2019)
  • K183020 — Endosee System (January 31, 2019)

Other clearances for product code HEW

  • K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (October 2, 2025)
  • K201086 — Advincula Delineator Uterine Manipulator (May 21, 2020)
  • K191294 — Transvaginal Access Platform (September 6, 2019)
  • K161065 — ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator (October 27, 2016)
  • 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)