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FDA 510(k)

ST-E1 OVERTUBE

K-Number: K903842 · 1991-01-23

ApplicantOlympus Corp.
Decision Date1991-01-23
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ST-E1 OVERTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1991-01-23 under 510(k) number K903842. 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 ST-E1 OVERTUBE?

ST-E1 OVERTUBE is a medical device that received FDA 510(k) clearance on 1991-01-23. The listed applicant is Olympus Corp.. The 510(k) number is K903842.

When did ST-E1 OVERTUBE receive FDA 510(k) clearance?

ST-E1 OVERTUBE received FDA 510(k) clearance on 1991-01-23, under 510(k) number K903842.

Who is the listed applicant for ST-E1 OVERTUBE?

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

What is the FDA product code for ST-E1 OVERTUBE?

The FDA product code for ST-E1 OVERTUBE is FED.

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Other records listing Olympus Corp. as applicant

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K915402EW-10 AND EW-20K933200OLYMPUS PBD STENTSK942338OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIESK931763HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESSK934835FLOVALK931764HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES

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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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