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FDA 510(k)

FUJINON STERILE OVERTUBES

K-Number: K091773 · 2009-08-07

ApplicantFujinon, Inc.
Decision Date2009-08-07
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJINON STERILE OVERTUBES is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 2009-08-07 under 510(k) number K091773. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJINON STERILE OVERTUBES?

FUJINON STERILE OVERTUBES is a medical device that received FDA 510(k) clearance on 2009-08-07. The listed applicant is Fujinon, Inc.. The 510(k) number is K091773.

When did FUJINON STERILE OVERTUBES receive FDA 510(k) clearance?

FUJINON STERILE OVERTUBES received FDA 510(k) clearance on 2009-08-07, under 510(k) number K091773.

Who is the listed applicant for FUJINON STERILE OVERTUBES?

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 STERILE OVERTUBES?

The FDA product code for FUJINON STERILE OVERTUBES is FED.

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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 PROCESSORK090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15K063316FUJINON MODEL EG-530N TRANS NASAL INSERTION

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Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

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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