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510(k) Data Aggregation
K Number
K072293Device Name
FOSSA URETERAL OPEN STENTS
Manufacturer
Date Cleared
2008-08-06
(356 days)
Product Code
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
FOSSA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fossa Ureteral OPEN-8 Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder and to inhibit microbial adherence on the catheter, specifically Proteus Mirabilus and Escherichia Coli.
Device Description
The Fossa Ureteral Open-8 Stent set consists of a flexible, piatail-tipped stent with a radiopaque push catheter. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent and two external grooves.
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K Number
K033368Device Name
FOSSA URETERAL OPEN LUMEN STENT
Manufacturer
Date Cleared
2003-11-26
(36 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
FOSSA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fossa Ureteral Open Lumen Stent is indicated for use as an indwelling ureteral catheter to promote drainage of urine from the kidney to the bladder.
Device Description
The Fossa Ureteral Open Lumen Stent set consists of a flexible, pigtail-tipped stent with: "Pusher." and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. The stent has two lumens open to the outside of the stent.
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K Number
K031292Device Name
MODIFICATION TO FOSSA URETERAL STONE SWEEPER
Manufacturer
Date Cleared
2003-05-22
(29 days)
Product Code
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
FOSSA MEDICAL, 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, Pigtail 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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