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510(k) K860771

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

K860771 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code GCQ (Endoscope, Flexible), a Class II device regulated under 21 CFR 876.1500. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

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.

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

FDA data resources