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510(k) Data Aggregation
K Number
K212868Device Name
JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
Manufacturer
Rocamed SAM
Date Cleared
2022-01-26
(139 days)
Product Code
FAD
Regulation Number
876.4620Why did this record match?
Applicant Name (Manufacturer) :
Rocamed SAM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JFil® Ureteral Stents are used for temporary internal drainage of the ureteropelvic junction.
The stents may be placed using endoscopic techniques.
The stents are not intended as permanent indwelling devices, it is recommended that the indwelling time does not exceed 14 days.
Target population: adults only (greater than 21 years of age).
Device Description
The JFil® Ureteral Stents consist of a tube-like device that is inserted into the ureter to allow the passage of the urine in the treatment of ureteral injuries and ureteral obstructions. This polyurethane stent has a single loop on the proximal tip and a polypropylene-monofilament surgical thread on the distal tip. JFil stents are 6.0 or 7.0 French (Fr) in diameter and 8 or 16 cm in specified length. The stent is provided with a 63 cm length pusher and may include a Nitinol Guidewire in the kit. The pusher consists of a radio-opaque ring connected to a tubing, and is intended to allow pushing, placing, and releasing the stent inside the patient. This stents can only be used by trained professionals in a clinic or hospitals environment. The JFil Ureteral Stents are sterile and for single use only. The stents are also available in ECO-kits which do not include a guidewire. The stents can be removed cystoscopically by gently pulling on the surgical thread.
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