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510(k) K864960

TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. by Cooper Lasersonics, Inc. — Product Code GCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1987
Date Received
December 22, 1986
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 Cooper Lasersonics, Inc.

  • K880807 — ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880429 — ILLUMINA 55 CO2 LASER SYSTEM (April 18, 1988)
  • K880427 — ILLUMINA 40 CO2 LASER SYSTEM (April 18, 1988)
  • K880809 — ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880428 — ILLUMINA 25 CO2 LASER SYSTEM (April 18, 1988)
  • K880808 — ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU (April 18, 1988)
  • K880171 — MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL (April 11, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS (March 24, 1988)
  • K880172 — MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. (March 11, 1988)

Other clearances for product code GCQ

  • K920979 — CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) (March 23, 1993)
  • K900894 — MEDILASE SERIES 2100 ENDOSCOPE (June 22, 1990)
  • K871978 — CODMAN FLEXIBLE ENDOSCOPE (August 25, 1987)
  • K860771 — VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE (April 23, 1986)