Who is the manufacturer of SUBCUTANEOUS URINARY DIVERSON STENT SET?

Cook Urological, Inc. filed the 510(k) submission for SUBCUTANEOUS URINARY DIVERSON STENT SET (K961371).

What is the FDA product code for SUBCUTANEOUS URINARY DIVERSON STENT SET?

FAD. It is classified under 21 CFR 876.4620 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for SUBCUTANEOUS URINARY DIVERSON STENT SET?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SUBCUTANEOUS URINARY DIVERSON STENT SET?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SUBCUTANEOUS URINARY DIVERSON STENT SET

K961371 · Cook Urological, Inc. · FAD · Jul 24, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K961371
Device Name	SUBCUTANEOUS URINARY DIVERSON STENT SET
Applicant	Cook Urological, Inc.
Product Code	FAD · Gastroenterology, Urology
Decision Date	Jul 24, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4620
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Subcutaneous Urinary Diversion Stent Set and Exchange Set is used to create a new tunnel leading from the renal pelvis to the urinary bladder for the purpose of providing decompression of the renal system.

Device Story

Device creates subcutaneous tunnel from renal pelvis to urinary bladder for renal decompression; set includes stent, dilators, sheaths, wire guides, needle, syringe; exchange set includes dilator, sheath, positioner, release sleeve, wire guide; intended for one-time use; operated by clinicians in surgical/urological settings; facilitates urinary drainage; provides therapeutic benefit by relieving renal system pressure.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stent and accessory set; materials consistent with predicate devices; single-use; sterilization via standard procedures; mechanical construction.

Indications for Use

Indicated for patients requiring decompression of the renal system via creation of a subcutaneous tunnel from the renal pelvis to the urinary bladder.

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.

Related Devices

K172527 — Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe · Cook Incorporated · Oct 19, 2017
K250824 — Percuflex 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 Set · Boston Scientific Corporation · Apr 15, 2025
K980889 — URESIL NEPHRO-URETERAL STENT · Uresil Corp. · Apr 8, 1998
K982974 — DD URETERAL STENT, INTEGRAL STENT · Rusch Intl. · Jul 2, 1999
K033210 — BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET · Bioteque Corp. · Dec 30, 2004

Submission Summary (Full Text)

{0} K961371 JUL 24 1996 17 510(k) Premarket Notification Subcutaneous Urinary Diversion Stent Set Cook Urological ## 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 8, 1996 ### Device Trade Name: Subcutaneous Urinary Diversion Stent Set Proposed Classification Name: Splint, Ureteral ### Predicate Devices: The Subcutaneous Urinary Diversion Stent Set is comprised of a stent and accessories which are equivalent to predicate devices in terms of indications for use, design, and materials of construction. ### Device Description: The Subcutaneous Urinary Diversion Stent Set and Exchange Set is used to create a new tunnel leading from the renal pelvis to the urinary bladder for the purpose of providing decompression of the renal system. The set contains a stent, dilators, sheaths, wire guides, needle syringe and the exchange set contains a dilator, sheath, positioner, release sleeve and wire guide. This device is intended for one-time use. ### 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, Inc. This device is similar with respect to indications for use, materials, and physical construction to predicate devices, thereby meeting the requirements for section 510(k) substantial equivalency.