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FDA 510(k)

MODIFICATION TO ENDO-EASE

K-Number: K062805 · 2006-10-13

ApplicantSpirus Medical, Inc.
Decision Date2006-10-13
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ENDO-EASE 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 2006-10-13 under 510(k) number K062805. 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 MODIFICATION TO ENDO-EASE?

MODIFICATION TO ENDO-EASE is a medical device that received FDA 510(k) clearance on 2006-10-13. The listed applicant is Spirus Medical, Inc.. The 510(k) number is K062805.

When did MODIFICATION TO ENDO-EASE receive FDA 510(k) clearance?

MODIFICATION TO ENDO-EASE received FDA 510(k) clearance on 2006-10-13, under 510(k) number K062805.

Who is the listed applicant for MODIFICATION TO ENDO-EASE?

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 MODIFICATION TO ENDO-EASE?

The FDA product code for MODIFICATION TO ENDO-EASE is FED.

Related Clinical Trials

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.

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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 INSTRUMENTK060235ENDO-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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