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FDA 510(k)

FUJIFILM Distal Cap Models 33-40

K-Number: K193123 · 2019-12-11

ApplicantFujifilm Corporation
Decision Date2019-12-11
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Distal Cap Models 33-40 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2019-12-11 under 510(k) number K193123. 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 Distal Cap Models 33-40?

FUJIFILM Distal Cap Models 33-40 is a medical device that received FDA 510(k) clearance on 2019-12-11. The listed applicant is Fujifilm Corporation. The 510(k) number is K193123.

When did FUJIFILM Distal Cap Models 33-40 receive FDA 510(k) clearance?

FUJIFILM Distal Cap Models 33-40 received FDA 510(k) clearance on 2019-12-11, under 510(k) number K193123.

Who is the listed applicant for FUJIFILM Distal Cap Models 33-40?

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 Distal Cap Models 33-40?

The FDA product code for FUJIFILM Distal Cap Models 33-40 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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