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Transvaginal Doppler Probe, Model 09-0006-02

by Vascular Control Systems, Inc.

510(k) K023024

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 NumberK023024 Date26 Sep 2002ClearedStatusActive

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Transvaginal Doppler Probe, Model 09-0006-02 is an ultrasonic diagnostic transducer designed for transvaginal use. It incorporates an 8 MHz pulsed-wave Doppler sensor to assess blood flow within uterine vessels bilaterally. This handheld device enables real-time Doppler ultrasound imaging, facilitating evaluation of vascular perfusion in gynecological assessments. Its compact, ring-handled design ensures ergonomic insertion and precise sensor placement.

This probe is intended for single-use applications in clinical settings and requires connection to a compatible Doppler transceiver (e.g., Vascular Technology, Inc. 8 MHz Selectable Channel). It is classified under 21 CFR 892.1570 as a Class I medical device and has received FDA 510(k) clearance under the Radiology review panel. Sterility and regulatory compliance are ensured through manufacturer validation, with no MRI safety considerations specified. Storage instructions are not detailed in the available data.

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Questions

AI-generated answers, 1 Oct 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 Transvaginal Doppler Probe 09-0006-02 used for?

    This probe is designed specifically for transvaginal Doppler ultrasound imaging to evaluate blood flow in uterine vessels bilaterally. The 8 MHz pulsed-wave Doppler sensor enables real-time assessment of vascular perfusion, which is critical for gynecological evaluations such as monitoring placental blood flow during pregnancy or diagnosing vascular-related conditions.

  • How is the Transvaginal Doppler Probe 09-0006-02 supplied and used?

    The probe is intended for single-use applications in clinical settings. It is a handheld device with a compact, ring-handled design for ergonomic insertion and precise sensor placement. To operate, it must be connected to a compatible Doppler transceiver, such as the Vascular Technology, Inc. 8 MHz Selectable Channel system, ensuring accurate Doppler ultrasound imaging.

  • Is the Transvaginal Doppler Probe 09-0006-02 sterile and reusable?

    The probe is designed for single-use only and is supplied in a sterile condition as validated by the manufacturer. It is not intended for reuse or reprocessing, adhering to standard single-use medical device practices to ensure patient safety and sterility.

  • What models or variations of this Doppler probe exist?

    The provided data specifies only one model of this probe: the Transvaginal Doppler Probe, Model 09-0006-02. No other models or variations are mentioned in the available documentation. Always verify compatibility with your Doppler transceiver system before use.

  • Are there any special storage instructions for this probe?

    The available documentation does not provide explicit storage instructions for the Transvaginal Doppler Probe, Model 09-0006-02. However, as a single-use device, it should be stored in a clean, dry environment, protected from physical damage and contamination until use. Follow general medical device storage guidelines unless manufacturer-specific instructions are provided.