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EPX-310 Video Processor (Endoscopy)

by Marks & Murase

510(k) K950417

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 NumberK950417 Date21 Jul 1995ClearedStatusActive

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  • Withdrawn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
FET
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 EPX-310 Video Processor (Endoscopy) is an Endoscopic Video Imaging System/Component, designed to process and enhance video signals from endoscopic procedures. It facilitates real-time imaging for diagnostic and therapeutic applications in gastroenterology and urology, ensuring clear visualization of internal anatomical structures during endoscopy.

This device is intended for use in clinical settings, supplied as a reusable medical instrument. It is not classified as MRI-safe or MRI-conditional, and no sterility claims are made. The EPX-310 was granted FDA 510(k) clearance under the Traditional pathway, with a decision date of July 21, 1995, and is regulated under FDA regulation number 876.1500. It falls under Class II device classification and is associated with product code FET.

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