Who is the manufacturer of KENDALL CURITY URETERAL CATHETER?

Kendall Healthcare Products Co. Div.Of Tyco Health filed the 510(k) submission for KENDALL CURITY URETERAL CATHETER (K964899).

What is the FDA product code for KENDALL CURITY URETERAL CATHETER?

EYB. It is classified under 21 CFR 876.5130 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for KENDALL CURITY URETERAL CATHETER?

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

Who can help prepare an FDA 510(k) submission like KENDALL CURITY URETERAL CATHETER?

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.

KENDALL CURITY URETERAL CATHETER

K964899 · Kendall Healthcare Products Co. Div.Of Tyco Health · EYB · Feb 7, 1997 · Gastroenterology, Urology

Device Facts

Record ID	K964899
Device Name	KENDALL CURITY URETERAL CATHETER
Applicant	Kendall Healthcare Products Co. Div.Of Tyco Health
Product Code	EYB · Gastroenterology, Urology
Decision Date	Feb 7, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2

Intended Use

The Kendall Curity Ureteral Catheter is intended to be used to inject contrast medium for fluoroscopic ureteral visualization, to direct a guidewire into the ureter and for urinary drainage.

Device Story

Sterile, single-use ureteral catheter; single-lumen nylon resin extrusion. Features graduated placement markers for depth monitoring; proximal friction-fitted luer lock adapter; distal tip available in cone, open, or whistle configurations. Length 70 cm; sizes 4.0 Fr. to 7.0 Fr. Used by urologists in clinical settings to facilitate ureteroscopy by directing guidewires, injecting contrast media for fluoroscopy, or providing urinary drainage. Device provides visual and mechanical guidance for procedural access to the ureter.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO-10993; functional/mechanical testing performed for flow rates, shaft kink, stiffness, tensile strength, tip/shaft bond, and radiopacity. Results demonstrate equivalence to predicate devices.

Technological Characteristics

Material: Nylon resin. Configuration: Single-lumen extrusion, 70 cm length, 4.0-7.0 Fr. Features: Graduated placement markers, luer lock adapter, variable distal tips (cone, open, whistle). Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients requiring ureteral visualization via contrast injection, guidewire placement, or urinary drainage during ureteroscopy procedures.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

Bard Ureteral Catheter (Pre-Amendment Device)
Cook Ureteral Catheter (K923729)

Related Devices

K220036 — Wellead Ureteral Catheter · Well Lead Medical Co., Ltd. · Dec 16, 2022
K021856 — PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX · Porges S.A. · Oct 17, 2002
K180182 — Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter · Cook Incorporated · Sep 14, 2018
K191187 — Dornier MINNOW Ureteral Catheter · Dornier Medtech America, Inc. · Sep 18, 2019
K180354 — UroGen Ureteral Catheter · Urogen Pharma, Ltd. · Oct 30, 2018

Submission Summary (Full Text)

{0} FEB - 7 1997 K964899 EXHIBIT #7 P192 # 510(k) Summary ## Kendall Curity® Ureteral Catheter In accordance with section 513(i) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by: Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 Date: November 25, 1996 ### 1. Contact Person David A. Olson Manager Regulatory Affairs (508) 261-8530 ### 2. Name of Medical Device Classification Name: Gastro-Urology Ureteral Catheter Common or Usual Name: Ureteral Catheter Proprietary Name: Curity Ureteral Catheter ### 3. Identification of Legally Marketed Device The proposed Kendall Curity Ureteral Catheter is substantially equivalent in intended use, design and function to the commercially available Bard Ureteral Catheter (Pre-Amendment Device); Cook Ureteral Catheter, 510(k) No. K923729. ### 4. Device Description The proposed Kendall Curity Ureteral Catheter is a sterile, single use device which facilitates preliminary procedural components of ureteroscopy. The catheter is a single lumen extrusion fabricated from nylon resin. Graduated placement markers on the catheter shaft will allow the urologist to determine the extent of catheter advancement. The proximal end of the catheter has a friction fitted luer lock adapter. The distal catheter tip will be manufactured in a cone tip, open tip or whistle tip configuration. The catheter will be sold in a standard 70 cm working length in French sizes ranging from 4.0 Fr. to 7.0 Fr. {1} K964899 p2012 ## 5. Device Intended Use The Kendall Curity Ureteral Catheter is intended to be used to inject contrast medium for fluoroscopic ureteral visualization, to direct a guidewire into the ureter and for urinary drainage. ## 6. Product Comparison The Kendall Curity Ureteral Catheter is equivalent to the referenced predicate devices in that they are fabricated from similar materials have the same function, equivalent indications for use, and similar designs. ## 7. Nonclinical Testing Biocompatibility testing was performed on the catheter following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances. Functional/Mechanical testing was performed to determine flow rates, shaft kink, shaft stiffness, shaft tensile, cone tip/shaft bond and shaft radiopacity. Testing showed equivalence between the proposed catheter and referenced predicate devices.