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HTx Disposable Hysteroscope System

by Acuvu, Inc.

510(k) K211227

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 NumberK211227 Date15 Sep 2021ClearedStatusActive

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  • Withdrawn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
HIH
Device Class
Class II
Regulation
21 CFR Part 884.1690
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 HTx Disposable Hysteroscope System is a hysteroscope (and accessories) device classified under medical specialty Obstetrics/Gynecology. It is a disposable system intended for viewing the cervical canal and uterine cavity to perform diagnostic and operative procedures.

The device is supplied as a single-use system and has received FDA 510(k) clearance (K211227) as substantially equivalent. It is used in clinical settings for hysteroscopy procedures and is compatible with tools that expand resection capabilities, with the portable video system enabling direct visualization.

Other devices from Acuvu, Inc.

Questions

AI-generated answers, 6 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 HTx Disposable Hysteroscope System used for?

    The HTx Disposable Hysteroscope System is intended for viewing the cervical canal and uterine cavity to perform diagnostic and operative hysteroscopy procedures, enabling direct visualization of the uterine cavity for clinical assessment and treatment.

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

    The HTx Disposable Hysteroscope System is supplied as a single-use system, meaning it is designed for one-time use only and should not be reprocessed or reused to ensure patient safety and device integrity.

  • What regulatory clearance does the HTx Disposable Hysteroscope System have?

    The HTx Disposable Hysteroscope System has received FDA 510(k) clearance (K211227) as substantially equivalent to a legally marketed predicate device, which allows it to be legally marketed in the United States for its intended use.