Flexible Liquid Light Guide

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K834487 ↗

FDA Product Code

FFS

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Endo Lase, Inc. →

• What is the Flexible Liquid Light Guide used for?

  The Flexible Liquid Light Guide is used to provide access, illumination, and enable observation or manipulation of body cavities, hollow organs, and canals during endoscopic procedures. It functions as an image, illumination, and fiberoptic device that transmits light and visual information to the user's eye when attached to an endoscope.

• How is the Flexible Liquid Light Guide supplied and is it reusable?

  The device is supplied as an accessory to endoscopes. The provided data does not specify whether it is single-use or reusable, so reuse status cannot be determined from the information given. It is intended to be used in conjunction with endoscopic systems for illumination and image transfer.

• What specialties is the Flexible Liquid Light Guide intended for?

  The device is classified for use in gastroenterology and urology specialties, as indicated by the product code FFS and the medical specialty description in the authorization data. It is designed to support endoscopic procedures in these clinical areas.

• What regulatory pathway was used for the Flexible Liquid Light Guide?

  The Flexible Liquid Light Guide received FDA 510(k) clearance under submission K834487, with a decision date of February 21, 1984. It was found substantially equivalent to a predicate device and is regulated as a Class II medical device.

• What is the product code and device class for the Flexible Liquid Light Guide?

  The device has the product code FFS and is classified as a Class II medical device. This classification is based on its regulation under 21 CFR 876.1500 and its intended use in gastroenterology and urology endoscopic procedures.