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FDA 510(k)

MODIFICATION TO FOSSA URETERAL STONE SWEEPER

K-Number: K031292 · 2003-05-22

ApplicantFossa Medical, Inc.
Decision Date2003-05-22
Product CodeFAD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FOSSA URETERAL STONE SWEEPER is the device name listed in this FDA 510(k) record. The listed applicant is Fossa Medical, Inc.. It received FDA 510(k) clearance on 2003-05-22 under 510(k) number K031292. 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 MODIFICATION TO FOSSA URETERAL STONE SWEEPER?

MODIFICATION TO FOSSA URETERAL STONE SWEEPER is a medical device that received FDA 510(k) clearance on 2003-05-22. The listed applicant is Fossa Medical, Inc.. The 510(k) number is K031292.

When did MODIFICATION TO FOSSA URETERAL STONE SWEEPER receive FDA 510(k) clearance?

MODIFICATION TO FOSSA URETERAL STONE SWEEPER received FDA 510(k) clearance on 2003-05-22, under 510(k) number K031292.

Who is the listed applicant for MODIFICATION TO FOSSA URETERAL STONE SWEEPER?

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

What is the FDA product code for MODIFICATION TO FOSSA URETERAL STONE SWEEPER?

The FDA product code for MODIFICATION TO FOSSA URETERAL STONE SWEEPER is FAD.

Related Clinical Trials

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.

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Other records listing Fossa Medical, 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.

K072293FOSSA URETERAL OPEN STENTSK033368FOSSA URETERAL OPEN LUMEN 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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