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Transvaginal Probe, Model ED65M-TV

by Elscint, Inc.

510(k) K861371

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 NumberK861371 Date14 Jul 1986ClearedStatusActive

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  • Withdrawn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
HGL
Device Class
Class II
Regulation
21 CFR Part 884.2960
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

This device is a transducer, ultrasonic, obstetric, designed for transvaginal use. It is classified under product code HGL and is intended for imaging pelvic structures, including the uterus and ovaries, particularly in early pregnancy assessment.

It was cleared by the FDA via the 510(k) pathway under K861371 on July 14, 1986, and is classified as a Class II device with special controls. The probe is manufactured by Elscint, Inc. and is supplied as a reusable endocavity ultrasound transducer for use in obstetrics and gynecology settings.

Other devices from Elscint, Inc.

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Questions

AI-generated answers, 28 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 TRANSVAGINAL PROBE, MODEL ED65M-TV used for?

    This device is an ultrasonic transducer designed for transvaginal use in obstetrics and gynecology, intended for imaging pelvic structures such as the uterus and ovaries, particularly during early pregnancy assessment.

  • Is the TRANSVAGINAL PROBE, MODEL ED65M-TV reusable or single-use?

    The probe is supplied as a reusable endocavity ultrasound transducer, meaning it is designed for multiple uses after proper cleaning and disinfection between patients, not as a single-use disposable device.

  • Who manufactures the TRANSVAGINAL PROBE, MODEL ED65M-TV and where are they located?

    The device is manufactured by Elscint, Inc., located at 751 Expy. Dr., Itasca, IL 60143, United States, as indicated in the manufacturer's address and registration details.