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FDA 510(k)

ENDO-EASE ENDOSCOPIC OVERTUBE

K-Number: K052084 · 2005-09-14

ApplicantSpirus Medical, Inc.
Decision Date2005-09-14
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDO-EASE ENDOSCOPIC OVERTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Spirus Medical, Inc.. It received FDA 510(k) clearance on 2005-09-14 under 510(k) number K052084. 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 ENDO-EASE ENDOSCOPIC OVERTUBE?

ENDO-EASE ENDOSCOPIC OVERTUBE is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is Spirus Medical, Inc.. The 510(k) number is K052084.

When did ENDO-EASE ENDOSCOPIC OVERTUBE receive FDA 510(k) clearance?

ENDO-EASE ENDOSCOPIC OVERTUBE received FDA 510(k) clearance on 2005-09-14, under 510(k) number K052084.

Who is the listed applicant for ENDO-EASE ENDOSCOPIC OVERTUBE?

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

What is the FDA product code for ENDO-EASE ENDOSCOPIC OVERTUBE?

The FDA product code for ENDO-EASE ENDOSCOPIC OVERTUBE is FED.

Related Clinical Trials

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Other records listing Spirus Medical, 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.

K080050SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBEK080042SPIRUS MEDICAL SURGICAL INSTRUMENTK062805MODIFICATION TO ENDO-EASEK060235ENDO-EASE ENDOSCOPIC OVERTUBE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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