Who is the manufacturer of CIRCLE NEPHROSTOMY CATHETER SET?

Cook Urological, Inc. submitted the Traditional clearance for CIRCLE NEPHROSTOMY CATHETER SET (K961933).

What is the FDA product code for CIRCLE NEPHROSTOMY CATHETER SET?

LJE. as a Class U device in the GU panel.

What is the regulatory pathway for CIRCLE NEPHROSTOMY CATHETER SET?

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

What are the predicate devices for CIRCLE NEPHROSTOMY CATHETER SET?

Silastic® U-Tube Nephrostomy Kit (Dow Corning Corporation); Circle Nephrostomy Tube (Mentor Urology).

CIRCLE NEPHROSTOMY CATHETER SET

K961933 · Cook Urological, Inc. · LJE · Jul 18, 1996 · GU

Device Facts

Record ID	K961933
Device Name	CIRCLE NEPHROSTOMY CATHETER SET
Applicant	Cook Urological, Inc.
Product Code	LJE · GU
Decision Date	Jul 18, 1996
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures.

Device Story

Circle Nephrostomy Catheter Set; used for urinary diversion post-nephrostomy or nephroureterostomy; facilitates drainage in stenotic/obstructed UPJ cases; device consists of catheter set; used by clinicians in clinical settings; provides mechanical diversion of urine; benefits patient by relieving obstruction and preventing hydronephrosis.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on silicone components; results confirm compliance with requirements. Polyvinylchloride and polypropylene components do not contact body tissue.

Technological Characteristics

Materials: silicone (patient-contacting), polyvinylchloride, and polypropylene (non-patient-contacting). Form factor: catheter set for urinary diversion. Sterilization: standard methods consistent with existing company products.

Indications for Use

Indicated for patients requiring temporary or permanent urinary diversion following nephrostomy, nephroureterostomy, or procedures for stenotic or obstructed ureteropelvic junction (UPJ).

Predicate Devices

Silastic® U-Tube Nephrostomy Kit (Dow Corning Corporation)
Circle Nephrostomy Tube (Mentor Urology)

Related Devices

K211911 — Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets · Coloplast Corp. · Mar 10, 2022
K974541 — MODIFIED URETERAL INDWELLING CATHETER/STENT · Boston Scientific Corp · Feb 9, 1998
K961371 — SUBCUTANEOUS URINARY DIVERSON STENT SET · Cook Urological, Inc. · Jul 24, 1996
K180029 — Malecot Nephrostomy Catheter/Stent Set · Cook Incorporated · Sep 21, 2018
K181735 — Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set · Cook Incorporated · Mar 27, 2019

Submission Summary (Full Text)

{0} 510(k) Premarket Notification Circle Nephrostomy Catheter Set Cook Urological, Incorporated ## J. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Submitted By: Rick Lykins Cook Urological, Incorporated 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 May 16, 1996 K961933 JUL 18 1996 ## Device: Trade Name: Circle Nephrostomy Catheter Set Proposed Classification Name: Catheter, Nephrostomy, General & Plastic Surgery 79 GBO ## Predicate Devices: The Circle Nephrostomy Catheter Set is substantially equivalent to predicate circle nephrostomy catheter sets in terms of indications for use, design, construction and materials equivalence. Predicate devices include: - Silastic® U-Tube Nephrostomy Kit manufactured by Dow Corning Corporation. - Circle Nephrostomy Tube manufactured by Mentor Urology ## Device Description: The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures. The materials used in this device are silicone, polyvinylchloride and polypropylene. Biocompatibility testing has been performed on the silicone. Results show the material to meet the requirements of these tests. The polyvinylchloride and polypropylene do not come into contact with body tissue. ## Substantial Equivalence: This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed by Cook Urological, Incorporated. 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.