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510(k) K122973

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE by Medgyn Products, Inc. — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2013
Date Received
September 26, 2012
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 Medgyn Products, Inc.

  • K143669 — MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI (November 23, 2015)
  • K945179 — BOTTLE COLLECTION SET (January 26, 1995)
  • K880196 — LAMINARIA (May 6, 1988)
  • K880195 — GYNESCOPE (March 14, 1988)

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)