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FDA 510(k)

FUJIFILM 600 Series Endoscope EG-600WR v2

K-Number: K180341 · 2018-08-03

ApplicantFujifilm Corporation
Decision Date2018-08-03
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM 600 Series Endoscope EG-600WR v2 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2018-08-03 under approval number K180341. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM 600 Series Endoscope EG-600WR v2?

FUJIFILM 600 Series Endoscope EG-600WR v2 is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Fujifilm Corporation. The 510(k) number is K180341.

When was FUJIFILM 600 Series Endoscope EG-600WR v2 approved by the FDA?

FUJIFILM 600 Series Endoscope EG-600WR v2 received FDA 510(k) clearance on 2018-08-03, under approval number K180341.

What company makes FUJIFILM 600 Series Endoscope EG-600WR v2?

FUJIFILM 600 Series Endoscope EG-600WR v2 is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM 600 Series Endoscope EG-600WR v2?

The FDA product code for FUJIFILM 600 Series Endoscope EG-600WR v2 is FDS.

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Related Devices (Code: FDS)

K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. K180292PENTAX Video Upper G.I. Scope EG34-i10Pentax Medical of America, Inc. K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation K180911Visura Technologies TEECAD SystemVisura Technologies, LLC K173004SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd.

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.

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