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510(k) K190187

Gynescope System by Illumigyn , Ltd. — Product Code HEX

K190187 is an FDA 510(k) premarket notification submitted by Illumigyn , Ltd. for the device "Gynescope System". The FDA issued a decision of Substantially Equivalent on May 8, 2019. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2019
Date Received
February 1, 2019
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 for product code HEX

  • K233043 — Smart Scope® CX (June 14, 2024)
  • 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)
  • K140754 — COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM (October 23, 2014)

FDA data resources