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FDA 510(k)

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L

K-Number: K183572 · 2019-07-16

ApplicantFujifilm Corporation
Decision Date2019-07-16
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-07-16 under 510(k) number K183572. 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 Models EG-760CT, EC-760P-V/L and EC-740T/L?

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Fujifilm Corporation. The 510(k) number is K183572.

When did FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L receive FDA 510(k) clearance?

FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L received FDA 510(k) clearance on 2019-07-16, under 510(k) number K183572.

Who is the listed applicant for FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L?

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 Models EG-760CT, EC-760P-V/L and EC-740T/L?

The FDA product code for FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L 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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