← Product Code [EZD](/productcode/EZD) · K253295 # Coude Sleeved IC; Coude Plus Sleeved IC (K253295) _Hollister Incorporated · EZD · May 18, 2026 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K253295 ## Device Facts - **Applicant:** Hollister Incorporated - **Product Code:** [EZD](/productcode/EZD.md) - **Decision Date:** May 18, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5130 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic, Pediatric ## Indications for Use This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder. ## Device Story The Coudé Sleeved IC and Coudé Pocket Sleeved IC are single-use, hydrophilic-coated intermittent catheters designed for urinary incontinence management. The device features a coudé (curved/Tiemann) tip and two drainage eyelets. It is constructed from thermoplastic elastomer (TPE) and is free of phthalates, PVC, and natural rubber latex. The catheter is lubricated via direct contact with hydration fluid and is available in 16-inch lengths with French sizes 12, 14, and 16. The device is E-beam sterilized and packaged in an easy-to-open foil laminate. It is intended for use in hospitals, home settings, and public places by patients or caregivers to drain urine from the bladder. The device functions by manual insertion into the urethra; the coudé tip facilitates navigation through the urethral path. The output is the drainage of urine from the bladder, which assists in managing urinary retention or incontinence. ## Clinical Evidence Bench testing only. Performance testing included size designation, lubricity, tensile strength, drainage funnel security, flow rate, kink stability, and peak tensile force. Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity) followed ISO 10993 standards. Sterilization and packaging integrity were validated per ISO 11137, ISO 11607, and ASTM standards. ## Technological Characteristics Materials: TPE tubing/funnel, TPE introducer tip, LDPE cap, aliphatic polyurethane film sleeve. Principle: Hydrophilic-coated intermittent catheter with coudé tip. Energy: None (manual). Dimensions: 16-inch length, Ch 12-16. Sterilization: E-beam (25-65kGy, SAL 10^-6). Standards: BS EN ISO 20696:2018, ISO 10993, ISO 11137, ISO 11607, ASTM F2096, ASTM F88. ## 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 - Sleeved IC 2 ([K233524](/device/K233524.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} FDA U.S. FOOD & DRUG ADMINISTRATION May 18, 2026 Hollister Incorporated Michelle Schiltz-Taing Regulatory Affairs Manager 2000 Hollister Drive Libertyville, Illinois 60048 Re: K253295 Trade/Device Name: Coude Sleeved IC; Coude Pocket Sleeved IC Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Dated: April 15, 2026 Received: April 15, 2026 Dear Michelle Schiltz-Taing: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: The Center for Devices and Radiological Health (CDRH) does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253295 - Michelle Schiltz-Taing Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2} K253295 - Michelle Schiltz-Taing Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, JESSICA K. NGUYEN -S Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} Coude Sleeved IC (Not Finalized) Page 9 of 36 | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253295 | ? | | Please provide the device trade name(s). | | ? | | Coude Sleeved IC (Not Finalized) Coude Plus Sleeved IC (Not Finalized) (To be determined) | | | | Please provide your Indications for Use below. | | ? | | This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K253295 Page 1 of 4 # 510(k) Summary Applicant: Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 Contact Person: Michelle Schiltz-Taing Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (t) 224-864-0431 Date Prepared: May 15, 2026 Trade Name: Coudé Sleeved IC and Coudé Pocket Sleeved IC Common Name: Catheter, Urethral Product Code: EZD (catheter, straight) Regulatory Class: Class II Classification Name: Urological catheter and accessories CFR: 21 CFR 876.5130 ## Predicate Device: Sleeved IC 2 by Hollister Incorporated. (K233524) The predicate has not been subject to a design-related recall. ## Indications for Use: | Predicate Sleeved IC 2 (K233524) 16" Product | Subject Coudé Sleeved IC & Coudé Pocket Sleeved IC * | | --- | --- | | This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder. | | ## Description of Applicant Device: The Coudé Straight Sleeved IC and Coudé Pocket Sleeved IC are: - E-beam sterilized. - Hydrophilic-coated, single use catheter. - Have two drainage eyelets that are used to manage urinary incontinence. - Have a coudé (Tiemann/Curved) tip - Inserted into the urethra to drain urine from the bladder. {5} K253295 Page 2 of 4 - Available in 16-inch lengths. - Available in Ch sizes ranging from Ch 12, Ch 14 and Ch16. - Made from Thermo-plastic Elastomer (TPE), not made with phthalates/not made with PVC/not made with natural rubber latex. - Packaged in a foil which was designed to be easy to open and to facilitate access to the catheter. - Lubricated by direct contact with the hydration fluid. - Available in straight and pocket packaging configurations ## Comparison of Technological Characteristics: The table below summarizes the technological characteristics of the Coudé Sleeved IC and Coudé Pocket Sleeved IC as compared to the predicate device. | | Predicate K233524 Sleeved IC 2 16” Product | Subject Coudé Sleeved IC & Coudé Pocket Sleeved IC | Same or Different/ Rationale for no impact to safety or efficacy | | --- | --- | --- | --- | | Indication for Use | This intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder. | | No change | | Condition of Use | Single use | | No change | | Ready to use | Yes | | No change | | Device Material | Thermo-plastic Elastomer (TPE); tubing and funnel | | No change | | | Not made with phthalates, not made with PVC | | | | | TPE Introducer Tip | | No change | | | Low density polyethylene cap | | No change | | | Aliphatic Polyurethane Film Sleeve | | No change | | Hydration Method | Direct hydration | | No change | | Hydrophilic Coating | Hydration fluid PVP Based (polyvinylpyrollidone) Coating | | No change | | Catheter length/ Fr. sizes | Standard with tip 16 inches: Fr 12, 14, 16 Pocket 16 inches: Fr 12, 14, 16 | | No change | {6} K253295 Page 3 of 4 | | Predicate K233524 Sleeved IC 2 16” Product | Subject Coudé Sleeved IC & Coudé Pocket Sleeved IC | Same or Different/ Rationale for no impact to safety or efficacy | | --- | --- | --- | --- | | Tip of catheter design | Rounded Tip (all sizes) | Coudé tip (all sizes) | Different tip profile/No impact to safety or efficacy. No new risks or changes to existing risks identified in risk assessment | | End Design | Standard with Tip and Pocket: Color coded funnel | | No change | | Catheter Eyelets | 2 smooth catheter eyelets | | No change | | Catheter Colour | Clear | | No change | | Not Made with Natural Rubber Latex | Yes | | No change | | Packaging Material | Aluminum Foil Laminate | | No change | | Sterilization Method | E-beam Irradiation Dose 25-65kGy SAL 10^{-6} | | No change | | Expiration Dating | 2 years | | No change | | Storage Conditions | 15-30° C / 59-86°F | | No change | | Environment of Use | Hospital Home Setting Public Places | | No change | ## Brief Description of Non-Clinical Testing: The physical performance properties of the Coudé Sleeved IC and Coudé Pocket Sleeved IC met all applicable requirements of BS EN ISO 20696:2018: Sterile urethral catheters for single use. Testing was conducted to support size designation, show equivalence of lubricity and determination of the strength of the catheter, security of fit of the drainage funnel, flow rate through catheter, catheter kink stability and peak tensile force. Testing of the urine collection bag was conducted to verify that the liquid would flow into the collection bag within one minute and to confirm sufficient flowrate. Biocompatibility testing met the following requirements: - ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process {7} K253295 Page 4 of 4 - ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity - ISO 10993-12:2021, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials - ISO 10993-17:2023-09 - ISO 10993-18: Second edition 2023-09 - ISO 10993-23, Biological evaluation of medical devices – Part 23 Tests for irritation The following biological endpoints were addressed: cytotoxicity, sensitization, irritation, acute systemic toxicity and subacute systemic toxicity. Sterilization met all requirements of the following FDA recognized standards: - ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. - ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - ANSI/AAMI/ISO 11737-1:2018, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - ANSI/AAMI/ISO 11737-2:2019, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process Both package integrity testing and bench performance testing were completed to support shelf life. Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted in order to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment. Packaging met all requirements of the following FDA recognized standards: - ISO 11607-1:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems - ISO 11607-2:2019 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly process - ASTM F2096-11(2019) Standard test method for detecting gross leaks in packaging internal pressurization (bubble test) - ASTM F88/F88M-23 Standard test method for seal strength of flexible barrier materials ## Conclusion: It is concluded that the information supplied in this submission has demonstrated that the safety and effectiveness of the Coudé Sleeved IC and Coudé Pocket Sleeved IC is substantially equivalent to the cleared predicate device. --- **Source:** [https://fda.innolitics.com/device/K253295](https://fda.innolitics.com/device/K253295) **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