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FDA 510(k)

UROSURGE SPIRASTENT PLUS URETERAL STENT

K-Number: K981489 · 1998-05-29

ApplicantUrosurge, Inc.
Decision Date1998-05-29
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROSURGE SPIRASTENT PLUS URETERAL STENT is the device name listed in this FDA 510(k) record. The listed applicant is Urosurge, Inc.. It received FDA 510(k) clearance on 1998-05-29 under 510(k) number K981489. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UROSURGE SPIRASTENT PLUS URETERAL STENT?

UROSURGE SPIRASTENT PLUS URETERAL STENT is a medical device that received FDA 510(k) clearance on 1998-05-29. The listed applicant is Urosurge, Inc.. The 510(k) number is K981489.

When did UROSURGE SPIRASTENT PLUS URETERAL STENT receive FDA 510(k) clearance?

UROSURGE SPIRASTENT PLUS URETERAL STENT received FDA 510(k) clearance on 1998-05-29, under 510(k) number K981489.

Who is the listed applicant for UROSURGE SPIRASTENT PLUS URETERAL STENT?

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

What is the FDA product code for UROSURGE SPIRASTENT PLUS URETERAL STENT?

The FDA product code for UROSURGE SPIRASTENT PLUS URETERAL STENT is FAD.

Related Clinical Trials

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Other records listing Urosurge, Inc. as applicant

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.

K992391UROSURGE SPIRALFLO URETERAL STENTK981491UROSURGE FILASTENT URETERAL STENT

Related Devices (Code: FAD)

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.

K251890Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., Ltd.K251469Endura™ Ureteral Stent and Stent SetCathegenix (Xiamen) Co., Ltd.K243039Ureteral Stents (AF-D series)Alton (Shanghai) Medical Instruments Co., Ltd.K243830Disposable ureteral stentShenzhen Trious Medical Technology Co., Ltd.K250824Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent SetBoston Scientific CorporationK232920RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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