Home / 510(k) Clearances / K820259

510(k) K820259

STERILE CYTOLOGY BRUSHES by American Endoscopy, Inc. — Product Code GEE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1982
Date Received
February 1, 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 American Endoscopy, Inc.

  • K853274 — AMERICAN DILATATION SYSTEM (October 17, 1985)
  • K841384 — PROXIMA 1 PH MONITOR (July 19, 1984)
  • K833491 — ENDO BITE BLOCK (April 25, 1984)
  • K840818 — BIOPSY FORCEPS (April 13, 1984)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K833492 — PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (November 29, 1983)
  • K832458 — AUTOMATIC ENDOSCOPE (October 20, 1983)
  • K821818 — RETRIEVAL BALLOONS (September 24, 1982)
  • K821819 — PIGTAIL STENTS (August 20, 1982)
  • K822062 — BALL TIP COAGULATING ELECTRODES (August 19, 1982)

Other clearances for product code GEE

  • K854003 — STERILE SOFT TISSUE BIOPSY NEEDLE (October 18, 1985)
  • K841008 — BIOPSY PUNCH, VARIOUS (June 8, 1984)
  • K822490 — DEFLECTING CYTOLOGY BRUSH (September 14, 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)