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510(k) K860771

VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE by Van-Tec, Inc. — Product Code GCQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
March 3, 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 Van-Tec, Inc.

  • K880096 — VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP (March 2, 1988)
  • K880099 — VAN-TEC BLADDER EVACUATOR (March 2, 1988)
  • K880095 — BERGER PROSTATE CULTURE CYTOLOGY BRUSH (March 2, 1988)
  • K880098 — VAN-TEC AUTO BIOPSY NEEDLE (March 2, 1988)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K874112 — VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (February 11, 1988)
  • K871779 — HELICAL STONE BASKET (DISPOSABLE) (June 17, 1987)
  • K871777 — VAN-TEC REUSABLE HELICAL STONE BASKET (June 17, 1987)
  • K870557 — VAN-TEC PUMPING SYSTEM (March 30, 1987)
  • K870679 — VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE (March 30, 1987)

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)
  • K864960 — TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. (February 10, 1987)