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Acueity Medical Light Source

by Acueity, Inc.

510(k) K032430

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 NumberK032430 Date5 Sep 2003ClearedStatusActive

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  • Withdrawn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
FCW
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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 Acueity Medical Light Source is a fiberoptic light source designed for use with endoscopes. Classified as a Class II medical device under FDA regulation 21 CFR 876.1500, it provides illumination for routine endoscopic procedures in gastroenterology and urology.

This device is supplied as a reusable medical instrument and is intended for use in controlled clinical settings. It operates under standard electrical safety standards and is not classified as MRI-safe or MRI-conditional. The device is authorized for use in the United States following FDA 510(k) clearance (K032430) and is distributed under product code FCW. Sterility is not applicable as it is a reusable device, and proper cleaning and maintenance protocols must be followed as per manufacturer guidelines.

Other devices from Acueity, Inc.

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.

  • Is the Acueity Medical Light Source intended for single-use or reusable applications in clinical settings?

    The Acueity Medical Light Source is designed as a reusable medical instrument for controlled clinical settings. Since it is not sterile by design, proper cleaning and maintenance protocols must be followed as outlined by the manufacturer to ensure safe and effective reuse.

  • What medical specialties is the Acueity Medical Light Source primarily used for according to its regulatory submissions?

    The device is primarily associated with the specialties of gastroenterology and urology, as indicated by its advisory committee classification and medical specialty description in the FDA submissions.

  • How is the Acueity Medical Light Source authorized for use in the United States?

    The Acueity Medical Light Source is authorized for use in the United States following FDA 510(k) clearance under the traditional review pathway, with clearance number K032430. It is classified as a Class II medical device under regulation 21 CFR 876.1500.

  • Does the Acueity Medical Light Source have any special considerations for use in MRI environments?

    No, the Acueity Medical Light Source is not classified as MRI-safe or MRI-conditional, meaning it should not be used in MRI environments unless explicitly approved for such use by the manufacturer.

  • What type of illumination does the Acueity Medical Light Source provide, and how is it connected to endoscopes?

    The Acueity Medical Light Source is a fiberoptic light source designed to provide illumination for routine endoscopic procedures. It is connected to endoscopes via fiberoptic cables, ensuring consistent and reliable light delivery during procedures in gastroenterology and urology.