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510(k) K201086

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2020
Date Received
April 23, 2020
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.

  • K243799 — Fetal Pillow (August 29, 2025)
  • K250438 — CooperSurgical Milex® Pessaries (April 11, 2025)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
  • 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)
  • K180429 — Advincula Delineator Uterine Manipulator (March 14, 2018)

Other clearances for product code HEW

  • K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device (October 2, 2025)
  • K191294 — Transvaginal Access Platform (September 6, 2019)
  • K180429 — Advincula Delineator Uterine Manipulator (March 14, 2018)
  • 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)