K961446 · Cook Urological, Inc. · FAD · May 28, 1996 · Gastroenterology, Urology
Device Facts
Record ID
K961446
Device Name
AQ HYDROPHILIC STENT
Applicant
Cook Urological, Inc.
Product Code
FAD · Gastroenterology, Urology
Decision Date
May 28, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.4620
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder.
Device Story
AQ Hydrophilic Stent provides temporary internal drainage from ureteropelvic junction to bladder; utilizes hydrophilic coating to become 'slippery-when-wet' to reduce friction during placement; used by urologists in clinical settings; device facilitates urine flow; benefits patient by minimizing trauma during insertion and maintaining ureteral patency.
Clinical Evidence
No clinical data provided; substantial equivalence established via bench-level comparison of materials, design, and intended use.
Technological Characteristics
Materials: polyurethane, silicone, hydrophilic coating. Form factor: ureteral stent. Sterilization: standard procedures consistent with marketed Cook Urological devices.
Indications for Use
Indicated for temporary internal drainage from the ureteropelvic junction to the bladder in patients requiring ureteral stenting.
Regulatory Classification
Identification
A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.
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K961446
510(k) Premarket Notification
AQ Hydrophilic Stent
Cook Urological
MAY 28 1996
## I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
### Submitted By:
Tammy Bacon
Cook Urological
1100 West Morgan Street
Spencer, Indiana 47460
(812) 829-4891
April 15, 1996
### Device
Trade Name: AQ Hydrophilic Stent
Proposed Classification Name: Splint, Ureteral
### Predicate Devices:
The AQ Hydrophilic Stent is substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Slipcoat™ Stent manufactured by Cook Urological, the Hydro-Plus™ manufactured by Microvasive and the Lubri-Flex™ Ureteral Stent, K905289, manufactured by Surgitek®.
### Device Description:
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder. The hydrophilic coating will allow the stent to become 'slippery-when-wet' which will reduce friction. This device will be made from polyurethane, silicone and a hydrophilic coating.
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510(k) Premarket Notification
AQ Hydrophilic Stent
Cook Urological
10
## Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
