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510(k) K900894

MEDILASE SERIES 2100 ENDOSCOPE by Medical Laser, Inc. — Product Code GCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1990
Date Received
February 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Flexible
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Other clearances by Medical Laser, Inc.

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  • K912265 — MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 (October 10, 1991)
  • K912447 — SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 (September 27, 1991)
  • K912089 — MODIFIED SERIES 2100 ENDOSCOPES (August 12, 1991)
  • K901464 — MEDILASE SERIES 2200 ENDOSCOPE (August 7, 1990)
  • K900380 — MEDILASE 5010 ENDOSCOPE CONSOLE (May 15, 1990)
  • K895837 — MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR (December 14, 1989)

Other clearances for product code GCQ

  • K920979 — CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) (March 23, 1993)
  • K871978 — CODMAN FLEXIBLE ENDOSCOPE (August 25, 1987)
  • K864960 — TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. (February 10, 1987)
  • K860771 — VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE (April 23, 1986)