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FDA 510(k)

SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE

K-Number: K080050 · 2008-05-06

ApplicantSpirus Medical, Inc.
Decision Date2008-05-06
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPIRUS MEDICAL 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 2008-05-06 under 510(k) number K080050. 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 SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE?

SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE is a medical device that received FDA 510(k) clearance on 2008-05-06. The listed applicant is Spirus Medical, Inc.. The 510(k) number is K080050.

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

SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE received FDA 510(k) clearance on 2008-05-06, under 510(k) number K080050.

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

The FDA product code for SPIRUS MEDICAL 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.

K080042SPIRUS MEDICAL SURGICAL INSTRUMENTK062805MODIFICATION TO ENDO-EASEK060235ENDO-EASE ENDOSCOPIC OVERTUBEK052084ENDO-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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