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FDA 510(k)

SPYSCOPE ACCESS AND DELIVERY CATHETER

K-Number: K051504 · 2005-06-16

ApplicantBoston Scientific Corp
Decision Date2005-06-16
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPYSCOPE ACCESS AND DELIVERY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2005-06-16 under 510(k) number K051504. 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 SPYSCOPE ACCESS AND DELIVERY CATHETER?

SPYSCOPE ACCESS AND DELIVERY CATHETER is a medical device that received FDA 510(k) clearance on 2005-06-16. The listed applicant is Boston Scientific Corp. The 510(k) number is K051504.

When did SPYSCOPE ACCESS AND DELIVERY CATHETER receive FDA 510(k) clearance?

SPYSCOPE ACCESS AND DELIVERY CATHETER received FDA 510(k) clearance on 2005-06-16, under 510(k) number K051504.

Who is the listed applicant for SPYSCOPE ACCESS AND DELIVERY CATHETER?

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

What is the FDA product code for SPYSCOPE ACCESS AND DELIVERY CATHETER?

The FDA product code for SPYSCOPE ACCESS AND DELIVERY CATHETER is FED.

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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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