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510(k) K822490

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

K822490 is an FDA 510(k) premarket notification submitted by Van-Tec, Inc. for the device "DEFLECTING CYTOLOGY BRUSH". The FDA issued a decision of Substantially Equivalent on September 14, 1982. The device falls under product code GEE (Brush, Biopsy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Van-Tec, Inc. has at least 10 other 510(k) clearances on record.

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.

  • 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 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)

FDA data resources