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510(k) K223064

ALLY II Uterine Positioning System™ (UPS) by CooperSurgical, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2022
Date Received
September 30, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by CooperSurgical, Inc.

  • K243799 — Fetal Pillow (August 29, 2025)
  • K250438 — CooperSurgical Milex® Pessaries (April 11, 2025)
  • 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)
  • K180429 — Advincula Delineator Uterine Manipulator (March 14, 2018)

Other clearances for product code LKF

  • K253403 — FemVue® Controlled Saline-Air Device (FSA-300) (December 15, 2025)
  • K252260 — RELIEEV HSG Catheter (HSG7FA1) (November 26, 2025)
  • K242002 — FemVue MINI Saline-Air Device (November 22, 2024)
  • K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0) (October 16, 2024)
  • K241693 — FemChec Controlled Saline-Air Device (FCD-250) (September 6, 2024)
  • K222798 — Rejoni Intrauterine Catheter (December 16, 2022)
  • K220202 — Uterine ElevatOR PRO with OccludOR Balloon (March 31, 2022)
  • K212505 — DUMI ManipulatOR (January 10, 2022)
  • K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (March 29, 2019)
  • K180300 — Margolin HSG Cannula, Goldstein Sonohysterography Catheter (October 26, 2018)