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Cox Disposable Cytology Brushes

by Cox Medical Ent., Inc. 2 variants

510(k) K912407

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912407 Date10 Sep 1991ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FDX
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cox Disposable Cytology Brushes are endoscopic cytology brushes intended for the collection of cellular specimens during endoscopic procedures. They are designed for use in gastroenterology and urology applications to obtain samples from mucosal surfaces for cytological analysis.

The brushes are supplied sterile, single‑use devices classified as Class II medical devices and cleared under FDA 510(k) submission K912407 (product code FDX, regulation 876.1500). They are disposable, intended for a single procedure, and are marketed in the United States by Cox Medical Ent., Inc.

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