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MBI Fiberoptic Endo-Illuminator

by M.B. Industries, Inc. 510(k)

Active United States

510(k) K961036

Overview

The MBI Fiberoptic Endo-Illuminator is a fiberoptic surgical field illuminator, designed to provide targeted illumination during endoscopic procedures. It delivers focused light to enhance visibility within confined anatomical spaces, supporting precise visualization for diagnostic and therapeutic interventions in gastroenterology and urology.

This device is supplied as a reusable medical instrument and is classified under FDA regulation 876.1500. It is intended for use in controlled clinical settings, adhering to standard sterilization protocols. The device holds an FDA 510(k) clearance (K961036) with a classification of Class II, approved under the Traditional 510(k) review pathway and substantiated as substantially equivalent to a predicate device. No MRI safety or single-use specifications are noted in the regulatory records.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961036 Date15 Jul 1996ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MPA
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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