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FDA 510(k)

FUJIFILM Endoscope Model EG-530N

K-Number: K183686 · 2019-02-28

ApplicantFujifilm Corporation
Decision Date2019-02-28
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscope Model EG-530N is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-02-28 under 510(k) number K183686. 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 Endoscope Model EG-530N?

FUJIFILM Endoscope Model EG-530N is a medical device that received FDA 510(k) clearance on 2019-02-28. The listed applicant is Fujifilm Corporation. The 510(k) number is K183686.

When did FUJIFILM Endoscope Model EG-530N receive FDA 510(k) clearance?

FUJIFILM Endoscope Model EG-530N received FDA 510(k) clearance on 2019-02-28, under 510(k) number K183686.

Who is the listed applicant for FUJIFILM Endoscope Model EG-530N?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Endoscope Model EG-530N?

The FDA product code for FUJIFILM Endoscope Model EG-530N is FDS.

Other records listing Fujifilm Corporation as applicant

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Related Devices (Code: FDS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm CorporationK253568Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STRFujifilm CorporationK251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)Pentax of America, Inc.K251041GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100Actuated Medical, 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.

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