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510(k) Data Aggregation
K Number
K021602Device Name
FOSSA URETERAL STONE SWEEPER
Manufacturer
Date Cleared
2002-07-26
(72 days)
Product Code
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
FOSSA INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fossa Ureteral Stone Sweeper is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder, and/or for the manipulation, capture and removal of urinary calculi.
Device Description
The Fossa Ureteral Stone Sweeper set consists of a flexible, Piqtail tipped, selfexpanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device, and to permit stone passage into the inner stent's lumen.
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K Number
K021140Device Name
FOSSA EXPANDING DOUBLE PIGTAIL URETERAL STENT
Manufacturer
Date Cleared
2002-06-28
(80 days)
Product Code
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
FOSSA INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fossa Double Pigtail Expanding Ureteral Stent is indicated for use as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.
Device Description
The Fossa Expanding Double Pigtail Ureteral Stent set consists of a flexible, Pigtail tipped, self-expanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device.
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