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FDA 510(k)

FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM

K-Number: K040048 · 2004-06-07

ApplicantFujinon, Inc.
Decision Date2004-06-07
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 2004-06-07 under 510(k) number K040048. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM?

FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-07. The listed applicant is Fujinon, Inc.. The 510(k) number is K040048.

When did FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM receive FDA 510(k) clearance?

FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM received FDA 510(k) clearance on 2004-06-07, under 510(k) number K040048.

Who is the listed applicant for FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM?

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 DOUBLE BALLOON ENTEROSCOPY SYSTEM?

The FDA product code for FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM is FDA.

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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: FDA)

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.

K260314Ancora-SBAspero Medical, Inc.K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas CorporationK233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas CorporationK231323Ancora-SBAspero Medical, Inc.K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm CorporatonK213195Balloon BS-3Fujifilm 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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