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FDA 510(k)

URETERAL ACCESS SHEATH SET - NEW MODELS

K-Number: K993650 · 1999-12-28

ApplicantApplied Medical Resources
Decision Date1999-12-28
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETERAL ACCESS SHEATH SET - NEW MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1999-12-28 under 510(k) number K993650. 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 URETERAL ACCESS SHEATH SET - NEW MODELS?

URETERAL ACCESS SHEATH SET - NEW MODELS is a medical device that received FDA 510(k) clearance on 1999-12-28. The listed applicant is Applied Medical Resources. The 510(k) number is K993650.

When did URETERAL ACCESS SHEATH SET - NEW MODELS receive FDA 510(k) clearance?

URETERAL ACCESS SHEATH SET - NEW MODELS received FDA 510(k) clearance on 1999-12-28, under 510(k) number K993650.

Who is the listed applicant for URETERAL ACCESS SHEATH SET - NEW MODELS?

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

What is the FDA product code for URETERAL ACCESS SHEATH SET - NEW MODELS?

The FDA product code for URETERAL ACCESS SHEATH SET - NEW MODELS 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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