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FDA 510(k)

GASTRO-INTESTINAL SYSTEM EN-410WM

K-Number: K993704 · 2000-02-11

ApplicantFujinon, Inc.
Decision Date2000-02-11
Product CodeFDA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GASTRO-INTESTINAL SYSTEM EN-410WM is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 2000-02-11 under 510(k) number K993704. 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 GASTRO-INTESTINAL SYSTEM EN-410WM?

GASTRO-INTESTINAL SYSTEM EN-410WM is a medical device that received FDA 510(k) clearance on 2000-02-11. The listed applicant is Fujinon, Inc.. The 510(k) number is K993704.

When did GASTRO-INTESTINAL SYSTEM EN-410WM receive FDA 510(k) clearance?

GASTRO-INTESTINAL SYSTEM EN-410WM received FDA 510(k) clearance on 2000-02-11, under 510(k) number K993704.

Who is the listed applicant for GASTRO-INTESTINAL SYSTEM EN-410WM?

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 GASTRO-INTESTINAL SYSTEM EN-410WM?

The FDA product code for GASTRO-INTESTINAL SYSTEM EN-410WM is FDA.

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Other records listing Fujinon, Inc. as applicant

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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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