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FDA 510(k)

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

K-Number: K162749 · 2017-06-15

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2017-06-15
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K162749. 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 Hood Models DH-28GR, DH-29CR and DH-30CR?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K162749.

When did FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR receive FDA 510(k) clearance?

FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR received FDA 510(k) clearance on 2017-06-15, under 510(k) number K162749.

Who is the listed applicant for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR?

The FDA product code for FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR is FDS.

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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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