← Product Code [EYB](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EYB) · K964899 # KENDALL CURITY URETERAL CATHETER (K964899) _Kendall Healthcare Products Co. Div.Of Tyco Health · EYB · Feb 7, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EYB/K964899 ## Device Facts - **Applicant:** Kendall Healthcare Products Co. Div.Of Tyco Health - **Product Code:** [EYB](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EYB.md) - **Decision Date:** Feb 7, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5130 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for 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. ## Regulatory 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](/device/K923729.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EYB/K964899](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/EYB/K964899) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com