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Diagnostic Dilatation & Menstrual Kit

by Intl. Medical Technologies, Inc.

510(k) K840384

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 NumberK840384 Date30 Apr 1984ClearedStatusActive

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  • Withdrawn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
HHI
Device Class
Class II
Regulation
21 CFR Part 884.5070
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 Diagnostic Dilatation & Menstrual Kit is a medical device used for diagnostic procedures in obstetrics and gynecology. It is classified as a System, Abortion, Vacuum and is designed for diagnostic dilatation procedures.

The device is supplied by Intl. Medical Technologies, Inc. and has FDA 510(k) clearance with number K840384. It is a Class II device with product code HHI and is regulated under number 884.5070. The device was received by the FDA on January 30, 1984, and deemed substantially equivalent on April 30, 1984.

Other devices from Intl. Medical Technologies, Inc.

Questions

AI-generated answers, 21 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 Diagnostic Dilatation & Menstrual Kit used for?

    The Diagnostic Dilatation & Menstrual Kit is used for diagnostic dilatation procedures in obstetrics and gynecology, as specified in its description as a System, Abortion, Vacuum designed for such diagnostic purposes.

  • How is the Diagnostic Dilatation & Menstrual Kit supplied and by whom?

    The device is supplied by Intl. Medical Technologies, Inc., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, as stated in the manufacturer and address details provided in the device data.

  • What is the regulatory status and classification of the Diagnostic Dilatation & Menstrual Kit?

    The device is a Class II medical device with product code HHI, regulated under 21 CFR 884.5070, and has FDA 510(k) clearance K840384, granted as substantially equivalent on April 30, 1984, following submission on January 30, 1984.