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510(k) K190639

Endosee System by CooperSurgical, Inc. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2019
Date Received
March 13, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by CooperSurgical, Inc.

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  • 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)
  • 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 HIH

  • K254251 — InnovexView (GC146-17, GC150-20, GC155-23) (February 26, 2026)
  • K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysterosc (December 18, 2025)
  • K252012 — SPY Cystoscope/Hysteroscope (July 18, 2025)
  • K243382 — RZ Resectoscope System (June 3, 2025)
  • K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, H (August 16, 2024)
  • K241987 — Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) (August 2, 2024)
  • K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS- (July 26, 2024)
  • K231260 — HTx Disposable Hysteroscope System (March 5, 2024)
  • K233635 — SPY Cystoscope/Hysteroscope (February 12, 2024)
  • K232003 — Endoscopic Video Image Processor, Single-Use Video Hysteroscope (February 12, 2024)