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Processor VP-7000, Light Source BL-7000

by Fujifilm Medical System U.S.A., Inc.

510(k) K163675

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 NumberK163675 Date25 Apr 2017ClearedStatusActive

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  • Withdrawn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, 21 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 Processor VP-7000 and Light Source BL-7000 together form an endoscopic video imaging system/component. This device is classified under Gastroenterology and Urology specialties and is designed for use in endoscopic procedures.

It is supplied as a reusable system and has received FDA 510(k) clearance under K163675. The device is intended for use in clinical settings and is not MRI safe unless otherwise specified. No sterility or single-use claims are present in the data.

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