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FDA 510(k)

DEFLECTING URETERAL ACCESS SHEATH

K-Number: K030642 · 2003-05-23

ApplicantApplied Medical Resources Corp.
Decision Date2003-05-23
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEFLECTING URETERAL ACCESS SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2003-05-23 under 510(k) number K030642. 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 DEFLECTING URETERAL ACCESS SHEATH?

DEFLECTING URETERAL ACCESS SHEATH is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K030642.

When did DEFLECTING URETERAL ACCESS SHEATH receive FDA 510(k) clearance?

DEFLECTING URETERAL ACCESS SHEATH received FDA 510(k) clearance on 2003-05-23, under 510(k) number K030642.

Who is the listed applicant for DEFLECTING URETERAL ACCESS SHEATH?

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

What is the FDA product code for DEFLECTING URETERAL ACCESS SHEATH?

The FDA product code for DEFLECTING URETERAL ACCESS SHEATH 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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