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Olympus MH-246R Balloon Sheath

by Olympus America, Inc.

510(k) K982725

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 NumberK982725 Date23 Oct 1998ClearedStatusActive

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  • Withdrawn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)

Full name
Olympus Mh-246R Balloon Sheath, for Female Reproductive Tract Use
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, 19 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 Olympus MH-246R Balloon Sheath is a medical device classified as a balloon catheter designed for intraluminal use in the female reproductive tract. It facilitates ultrasonic imaging by providing a protective and distensible pathway for an ultrasonic probe, enabling visualization of internal structures during diagnostic procedures.

This single-use device is intended for use with the Olympus Ultrasonic Probes UM-2R/UM-3R and is supplied sterile. It is regulated under the FDA’s 510(k) clearance (K982725) and falls under the ITX product code, with a decision of Substantially Equivalent (SESE) dated October 23, 1998. The device is not MRI-safe and must be handled in accordance with sterile medical device protocols.

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Questions

AI-generated answers, 19 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 Olympus MH-246R Balloon Sheath specifically designed for in medical procedures?

    The Olympus MH-246R Balloon Sheath is designed for use in the female reproductive tract to facilitate ultrasonic imaging. It acts as a protective, distensible pathway for an ultrasonic probe (compatible with Olympus UM-2R/UM-3R probes), allowing clearer visualization of internal structures during diagnostic procedures.

  • Is the MH-246R Balloon Sheath intended for reuse or is it meant to be used only once?

    The Olympus MH-246R Balloon Sheath is explicitly labeled as a single-use device. This classification ensures patient safety and sterility, as it is supplied sterile and must not be reused after one procedure.

  • What types of ultrasonic probes can be used with this balloon sheath, and how is it supplied?

    The MH-246R Balloon Sheath is designed exclusively for use with Olympus Ultrasonic Probes UM-2R and UM-3R. It is supplied sterile and ready for immediate use, eliminating the need for additional sterilization steps before deployment.

  • How should the MH-246R Balloon Sheath be stored, and are there any special handling requirements?

    Since the device is sterile, it must be stored in its original packaging until use to maintain sterility. Handling should follow standard sterile medical device protocols, including avoiding contamination or exposure to moisture. The balloon sheath is not MRI-safe, so it should not be used or stored near MRI equipment.