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FG-36UX Fiber Ultrasound Gastroscope

by Pentax Precision Instrument Corp.

510(k) K010740

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 NumberK010740 Date17 Apr 2001ClearedStatusActive

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  • Withdrawn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
ODG
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 FG-36UX Fiber Ultrasound Gastroscope is an Endoscopic Ultrasound System designed for optical and ultrasonic visualization of the upper gastrointestinal tract. It combines fiber-optic imaging with ultrasound capabilities to enable detailed examination of organs, tissues, and subsystems—including the esophagus, stomach, and small bowel—while also providing therapeutic access.

This device is intended for use in clinical settings and is supplied as a reusable medical instrument. It is classified under FDA regulation 876.1500 and holds a FDA 510K clearance (K010740) for substantial equivalence. The FG-36UX is not specified as single-use or sterile but is regulated under Class II medical device standards for endoscopic ultrasound systems in gastroenterology and urology.

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