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510(k) K822490

DEFLECTING CYTOLOGY BRUSH by Van-Tec, Inc. — Product Code GEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1982
Date Received
August 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Brush, Biopsy, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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 GEE

  • K854003 — STERILE SOFT TISSUE BIOPSY NEEDLE (October 18, 1985)
  • K841008 — BIOPSY PUNCH, VARIOUS (June 8, 1984)
  • K820259 — STERILE CYTOLOGY BRUSHES (March 5, 1982)
  • K812694 — WHISK-R (October 26, 1981)
  • K801304 — CAMLOC SYRINGE BIOPSY KIT (June 17, 1980)
  • K792316 — TROTEX II SCREW NEEDLE BIOPSY INSTR. SET (December 18, 1979)