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FDA 510(k)

COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH

K-Number: K043418 · 2005-03-31

ApplicantCook Urological, Inc.
Decision Date2005-03-31
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2005-03-31 under 510(k) number K043418. 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 COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH?

COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH is a medical device that received FDA 510(k) clearance on 2005-03-31. The listed applicant is Cook Urological, Inc.. The 510(k) number is K043418.

When did COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH receive FDA 510(k) clearance?

COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH received FDA 510(k) clearance on 2005-03-31, under 510(k) number K043418.

Who is the listed applicant for COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH?

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

What is the FDA product code for COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH?

The FDA product code for COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH is FED.

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Other records listing Cook Urological, Inc. as applicant

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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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