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FDA 510(k)

NAVIGATOR HD URETERAL ACCESS SHEATH SET

K-Number: K122649 · 2012-12-12

ApplicantBoston Scientific Corp
Decision Date2012-12-12
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR HD URETERAL ACCESS SHEATH SET 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 2012-12-12 under 510(k) number K122649. 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 NAVIGATOR HD URETERAL ACCESS SHEATH SET?

NAVIGATOR HD URETERAL ACCESS SHEATH SET is a medical device that received FDA 510(k) clearance on 2012-12-12. The listed applicant is Boston Scientific Corp. The 510(k) number is K122649.

When did NAVIGATOR HD URETERAL ACCESS SHEATH SET receive FDA 510(k) clearance?

NAVIGATOR HD URETERAL ACCESS SHEATH SET received FDA 510(k) clearance on 2012-12-12, under 510(k) number K122649.

Who is the listed applicant for NAVIGATOR HD URETERAL ACCESS SHEATH SET?

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 NAVIGATOR HD URETERAL ACCESS SHEATH SET?

The FDA product code for NAVIGATOR HD URETERAL ACCESS SHEATH SET 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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