Home / 510(k) Clearances / K140754

510(k) K140754

COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM by CooperSurgical, Inc. — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2014
Date Received
March 26, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colposcope (And Colpomicroscope)
Device Class
Class II
Regulation Number
884.1630
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)
  • 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 HEX

  • K233043 — Smart Scope® CX (June 14, 2024)
  • K190187 — Gynescope System (May 8, 2019)
  • K182764 — Biop Digital Colposcope (November 27, 2018)
  • K181034 — Pocket Colposcope System (September 21, 2018)
  • K170446 — LT-300 SD Digital Video Colposcope (May 21, 2017)
  • K161871 — EVA (Enhanced Visual Assessment) System (December 19, 2016)
  • K160341 — Colposcope System (September 14, 2016)
  • K160380 — LT-300 HD (May 13, 2016)
  • K151878 — Video Colposcope (December 1, 2015)
  • K143119 — LT-300 Video Colposcope (December 18, 2014)