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FDA 510(k)

FUJIFILM Endoscope Model EI-740D/S

K-Number: K221551 · 2023-01-27

ApplicantFujifilm Corporaton
Decision Date2023-01-27
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscope Model EI-740D/S is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K221551. 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 EI-740D/S?

FUJIFILM Endoscope Model EI-740D/S is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Fujifilm Corporaton. The 510(k) number is K221551.

When did FUJIFILM Endoscope Model EI-740D/S receive FDA 510(k) clearance?

FUJIFILM Endoscope Model EI-740D/S received FDA 510(k) clearance on 2023-01-27, under 510(k) number K221551.

Who is the listed applicant for FUJIFILM Endoscope Model EI-740D/S?

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

What is the FDA product code for FUJIFILM Endoscope Model EI-740D/S?

The FDA product code for FUJIFILM Endoscope Model EI-740D/S is FDS.

Other records listing Fujifilm Corporaton as applicant

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.

K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DK220957FUJIFILM Endoscope Model EB-710PK212950FUJIFILM Video Laparoscope EL-R740M30K203717Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0K200973Synapse 3D Cardiac Tools

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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