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HTx Disposable Hysteroscope System

by Suzhou AcuVu medical technology Co., Ltd.

510(k) K231260

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231260↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK231260 Date5 Mar 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 HTx Disposable Hysteroscope System is a single-use diagnostic and operative hysteroscopy device designed for visualizing and treating the uterine cavity. Classified as a Hysteroscope (and Accessories), it enables direct inspection, biopsy, and minimally invasive procedures within the uterus under direct visualization.

Intended for use in obstetrics and gynecology settings, this system is supplied sterile and intended for single-use only. It is regulated under FDA 510(k) clearance (K231260) and MDR, with multiple FEI and registration numbers listed. The device is non-magnetic and compatible with MRI environments, though specific sizes or accessories may vary as indicated by the associated product codes.

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Questions

AI-generated answers, 18 Sep 2026

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

  • Is the HTx Disposable Hysteroscope System reusable or intended for single-use only?

    The HTx Disposable Hysteroscope System is explicitly designed for single-use only, as stated in the manufacturer’s description. This ensures patient safety and sterility, as each system is supplied sterile and intended to be discarded after one procedure.

  • What types of procedures can this device be used for in the uterine cavity?

    The HTx Disposable Hysteroscope System is designed for diagnostic visualization and operative procedures within the uterine cavity, including direct inspection and biopsy. It supports minimally invasive interventions under direct visualization, commonly used in obstetrics and gynecology settings.

  • Are there different sizes or models available for this hysteroscope system?

    While the provided data lists multiple FEI and registration numbers, it does not specify exact sizes or models. However, the system is categorized under the Hysteroscope (and Accessories) product code (HIH), suggesting variability in accessories or scopes may exist. For precise sizing, refer to the manufacturer’s catalog or technical documentation.

  • Can this device be used in an MRI environment?

    Yes, the HTx Disposable Hysteroscope System is non-magnetic, making it compatible with MRI environments. However, specific accessories or components may have their own MRI compatibility considerations, so always verify with the manufacturer’s guidelines for the exact configuration being used.

  • How should the HTx Disposable Hysteroscope System be stored before use?

    The system is supplied sterile, so storage instructions typically include maintaining sterility until use. While not explicitly detailed here, standard practices for single-use disposable medical devices recommend storing in a clean, dry environment, away from direct sunlight or extreme temperatures, and following the manufacturer’s shelf-life guidelines.