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Endoscopic Fiberoptic Cable

by Isolux America

510(k) K991208

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK991208 Date23 Jun 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HBI
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
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.

An endoscopic fiberoptic cable is a device used for transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes, and endoscopes. It provides illumination in body cavities during examinations or surgical procedures.

The device is a Class 2 General & Plastic Surgery device with product code HBI, cleared through the FDA 510(k) Traditional pathway under K991208. It is supplied as a reusable component for use with compatible endoscopic systems and is intended for use in clinical settings requiring surgical field illumination.

Other devices from Isolux America

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 endoscopic fiberoptic cable used for?

    The endoscopic fiberoptic cable is used for transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes, and endoscopes, providing illumination in body cavities during examinations or surgical procedures.

  • Is the endoscopic fiberoptic cable reusable or single-use?

    The endoscopic fiberoptic cable is supplied as a reusable component for use with compatible endoscopic systems, meaning it is designed for multiple uses after proper cleaning and reprocessing in accordance with manufacturer instructions.

  • What regulatory pathway was used for the endoscopic fiberoptic cable?

    The endoscopic fiberoptic cable was cleared through the FDA 510(k) Traditional pathway under K991208, demonstrating substantial equivalence to a legally marketed predicate device.