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Pap Smear Kit

by Intl. Cytobrush, Inc.

510(k) K861389

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 NumberK861389 Date2 May 1986ClearedStatusActive

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  • Withdrawn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)

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, 26 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 Pap Smear Kit is a cervical cytological spatula used for the collection of clinical specimens. It is classified as a class 2 medical device under the medical specialty of obstetrics and gynecology.

This device is identified by K-number K861389 and is subject to FDA 510(k) clearance. It is regulated under 21 CFR 884.4530.

Other devices from Intl. Cytobrush, Inc.

Questions

AI-generated answers, 26 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 purpose of the Pap Smear Kit?

    The Pap Smear Kit is a cervical cytological spatula designed specifically for the collection of clinical specimens during gynecological examinations.

  • What is the regulatory status of this device?

    This device is classified as a class 2 medical device under 21 CFR 884.4530 and has received FDA 510(k) clearance under K-number K861389.

  • Which medical specialty uses this device?

    The Pap Smear Kit is intended for use within the medical specialty of obstetrics and gynecology, as indicated by its classification and advisory committee oversight.