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510(k) K940094

COLPOSCOPES AND ACCESSORIES by Leisegang Medical, Inc. — Product Code HEX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1995
Date Received
January 7, 1994
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 Leisegang Medical, Inc.

  • K990043 — SMOOTHLASE ALEXANDRITE LASER SYSTEM (February 11, 1999)
  • K924134 — LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS (July 2, 1993)
  • K920217 — MAX-E-VAC (July 23, 1992)
  • K914201 — LM- LAP 10 HIGH FLOW INSUFFLATOR (January 9, 1992)
  • K912789 — LM-100/200LOW FLOW INSUFFLATOR (September 20, 1991)
  • K913135 — LM-300TWIN (September 18, 1991)
  • K911212 — LM-150HT LIGHT SOURCE (May 23, 1991)
  • K902313 — LM-1Z ZOOM SCOPE (September 4, 1990)
  • K854767 — LM 1000 (January 24, 1986)

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)