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FDA 510(k)

FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5

K-Number: K042043 · 2004-11-24

ApplicantFujinon, Inc.
Decision Date2004-11-24
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K042043. 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 FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5?

FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Fujinon, Inc.. The 510(k) number is K042043.

When did FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 receive FDA 510(k) clearance?

FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042043.

Who is the listed applicant for FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5?

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

What is the FDA product code for FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5?

The FDA product code for FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 is FDS.

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Other records listing Fujinon, Inc. 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.

K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2K112391FUJINON COLONOSCOPESK102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSORK111243FUJINON ULTRASONIC PROCESSORK091773FUJINON STERILE OVERTUBESK090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15

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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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

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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