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510(k) K912407

COX DISPOSABLE CYTOLOGY BRUSHES by Cox Medical Ent., Inc. — Product Code FDX

K912407 is an FDA 510(k) premarket notification submitted by Cox Medical Ent., Inc. for the device "COX DISPOSABLE CYTOLOGY BRUSHES". The FDA issued a decision of Substantially Equivalent on September 10, 1991. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Cox Medical Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1991
Date Received
May 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

Other clearances by Cox Medical Ent., Inc.

  • K946360 — MODULAR BIOPSY FORCEP (March 6, 1995)
  • K950689 — UCB (March 6, 1995)
  • K941464 — BASICS ENDOSCOPY SYSTEM (August 5, 1994)
  • K940911 — BASICS ENDOSCOPY SYSTEM (May 16, 1994)
  • K932790 — THERMAL OPTION (January 28, 1994)
  • K935250 — ACCU-PATH (January 21, 1994)
  • K924655 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) (December 15, 1992)
  • K923671 — COX DISPOSABLE POLYPECTOMY SNARES (October 13, 1992)
  • K923489 — COX DISPOSABLE RETRIEVAL DEVICES (September 23, 1992)
  • K923672 — COX DISPOSABLE ENDOSCOPE CLEANING BRUSH (September 23, 1992)

Other clearances for product code FDX

  • K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
  • K220063 — Single Use Cytology Brush (July 28, 2022)
  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)
  • K191485 — Deflectable Brush Biopsy Set (June 26, 2019)
  • K182231 — Brush Biopsy Set ; Deflectable Brush Biopsy Set (May 1, 2019)
  • K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (February 8, 2019)
  • K172663 — Cytology Brush (March 5, 2018)
  • K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (December 29, 2017)
  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K151889 — Infinity ERCP Sampling Device (July 30, 2015)

FDA data resources