Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FUJIFILM Endoscope Models EC-600HL and EC-600LS

K-Number: K180405 · 2018-03-15

ApplicantFujifilm Corporation
Decision Date2018-03-15
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscope Models EC-600HL and EC-600LS is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2018-03-15 under approval number K180405. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Endoscope Models EC-600HL and EC-600LS?

FUJIFILM Endoscope Models EC-600HL and EC-600LS is a medical device that received FDA 510(k) clearance on 2018-03-15. It is manufactured by Fujifilm Corporation. The 510(k) number is K180405.

When was FUJIFILM Endoscope Models EC-600HL and EC-600LS approved by the FDA?

FUJIFILM Endoscope Models EC-600HL and EC-600LS received FDA 510(k) clearance on 2018-03-15, under approval number K180405.

What company makes FUJIFILM Endoscope Models EC-600HL and EC-600LS?

FUJIFILM Endoscope Models EC-600HL and EC-600LS is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Endoscope Models EC-600HL and EC-600LS?

The FDA product code for FUJIFILM Endoscope Models EC-600HL and EC-600LS is FDF.

Other Devices by Fujifilm Corporation

K182051FUJIFILM Duodenoscope Model K181773Synapse 3D Optional Tools K180341FUJIFILM 600 Series Endoscope EG-600WR v2 K181763FUJIFILM Ultrasonic Endoscope K180711FUJIFILM Endoscopic CO2 Regulator GW-100 K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603

View all 62 devices →

Related Devices (Code: FDF)

K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC K162622Fujifilm Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc. K160015Pure VuMotus GI Medical Technologies , Ltd. K161355invendoscopy E200 SystemInvendo Medical GmbH K161791Aer-O-Scope Colonoscope SystemGi View , Ltd. K160356Third Eye Panoramic Auxiliary Endoscopy System - ResposableAvantis Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑