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Cytette Cytology Brush

by Birchwood Laboratories, Inc.

510(k) K902591

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK902591 Date10 Sep 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Cytette(Tm) Cytology Brush
510(k) Number
FDA Product Code
HHT
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Cytette Cytology Brush is a cervical cytological spatula used for the collection of cellular samples. It features a tapered head designed to facilitate introduction into the cervix and soft nylon bristles to assist in obtaining specimens.

This device is regulated under FDA 510(k) clearance K902591. It is intended for use in obstetrics and gynecology settings.

Other devices from Birchwood Laboratories, Inc.

  • Cytoset(Tm)

    Class II

Questions

AI-generated answers, 24 Sep 2026

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

  • What is the primary use of the Cytette Cytology Brush?

    The Cytette Cytology Brush is a cervical cytological spatula designed for use in obstetrics and gynecology settings. It is specifically intended for the collection of cellular samples from the cervix.

  • How does the design of the brush assist in specimen collection?

    The device features a tapered head that is designed to facilitate easy introduction into the cervix. Additionally, it utilizes soft nylon bristles to assist in the effective collection of cellular specimens.

  • What is the regulatory status of this device?

    The Cytette Cytology Brush is regulated under FDA 510(k) clearance K902591. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the obstetrics and gynecology medical specialty.