Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)

Q: Who is the manufacturer of Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)?

Coloplast filed the 510(k) submission for Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) (K230165).

Q: What is the FDA product code for Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)?

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

Q: What is the regulatory pathway for Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)?

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

Q: What are the predicate devices for Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)?

SpeediCath Flex Coude Pro (K190620).

Q: Who can help prepare an FDA 510(k) submission like Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)?

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.

K230165 · Coloplast · EZD · Aug 25, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K230165
Device Name	Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)
Applicant	Coloplast
Product Code	EZD · Gastroenterology, Urology
Decision Date	Aug 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5130
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the bladder allowing urine to drain. The product is for adult male patients only.

Device Story

Luja Coude is a single-use, sterile, intermittent urinary catheter for adult males. Device features a flexible curved tip and a drainage zone containing multiple micro-holes to facilitate urine flow from the bladder. The catheter is coated with a hydrophilic polyvinylpyrrolidone (PVP) layer, activated by a saline/PEG wetting agent, to reduce friction during insertion. The device includes a protective sleeve and an outlet connector for attachment to a urine collection bag. Used in clinical or home settings, the catheter is operated by the patient or a caregiver to manage voiding dysfunction. By providing a reliable drainage path, the device assists in bladder emptying, reducing the risk of complications associated with urine retention. The device is sterilized via e-beam irradiation.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993 series), catheter performance (ISO 20696, ASTM F623-19), friction testing (ASTM D1894, TM 6058), and packaging integrity (ISO 11607-1, ASTM F2096, ASTM F88, ASTM D4169). Accelerated aging (ASTM F1980) confirmed shelf-life stability. Usability engineering was performed per EN/IEC 62366-1.

Technological Characteristics

Materials: Polyurethane catheter, PVP hydrophilic coating, saline/PEG wetting agent, thermoplastic polypropylene connectors/handle, copoly protective sleeve. Dimensions: 33cm length, 8-16 Fr diameters. Principle: Hydrophilic-coated intermittent catheter with flexible curved tip and micro-hole drainage zone. Sterilization: E-beam (SAL 10^-6). Standards: ISO 10993, ISO 20696, ASTM F623, ASTM D1894, ISO 11607, ASTM F1980.

Indications for Use

Indicated for adult male patients with urine retention and post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction.

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

SpeediCath Flex Coude Pro (K190620)

Reference Devices

SpeediCath Standard (K180258)

Related Devices

K241210 — Luja Coude · Coloplast Corp. · Nov 21, 2024
K251116 — Luja Coudé · Coloplast Corp. · Jun 27, 2025
K233101 — Luja Coude (20108 Male CH18 - large packaging) · Coloplast Corp. · Oct 26, 2023
K161672 — SpeediCath Flex Coude · Coloplast Corp. · Sep 29, 2016
K250270 — Luja Set · Coloplast Corp. · Apr 17, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 25, 2023 Coloplast Corporation Troy Thome Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411 Re: K230165 Trade/Device Name: Luja Coude Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: July 28, 2023 Received: July 28, 2023 Dear Troy Thome: 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 (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 located 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: 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, FDA may publish further announcements concerning your device in the Federal Register. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230165 Device Name Luja Coude #### Indications for Use (Describe) Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the bladder allowing urine to drain. The product is for adult male patients only. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a blue globe-like icon on the left and the word "Coloplast" in blue on the right. The globe icon has several horizontal white lines across it. # TRADITIONAL 510(K) SUMMARY | Submitted by: | Coloplast A/S Holtedam1 3050 Humlebaek Denmark | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Troy Thome Sr. Regulatory Affairs Specialist Coloplast 1601 West River Road North Minneapolis MN 55411 Phone: +1 (612)-356-9917 Email: ustbthome@coloplast.com | | Date of Summary: | August 24, 2023 | | Subject Device: | | | Trade or Proprietary Name: | Luja Coude | | Item/Model Numbers: | 20118, 20111, 20112, 20114, 20101, 20102, 20104, 20106 | | Common Name: | Urological catheter and accessories | | Regulation/Classification Name: | Urological catheter and accessories | | Regulation Number: | 21 CFR 876.5130 | | Regulatory Class: | II | | Product Code: | EZD | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for Coloplast. The logo consists of a blue globe-like icon on the left and the word "Coloplast" in blue, sans-serif font on the right. The globe icon is made up of several horizontal lines, with the lower half filled in with solid blue. | Review Panel: | Gastroenterology/Urology | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device: | K190620, SpeediCath Flex Coude Pro The predicate device has not been subject of a design-related recall. | | Reference Device: | K180258, SpeediCath Standard The reference device has not been subject of a design-related recall. | | Device Description: | Luja Coude is a single-use, sterile catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, and 16 Fr. The reference device supports the inclusion of 8 Fr models. | | Indications for Use: | Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. The product is for adult male patients only. The subject and predicate devices have the same intended use. | ## Technological Characteristics Comparison The table below summarizes the technological characteristics of Luja Coude as compared to the predicate device. | Parameter | Subject device | Predicate device | Reference device | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Luja Coude | SpeediCath Flex Coudé Pro | SpeediCath Standard (male models only) | | 510(k) Number | Unassigned | K190620 | K180258 | | Regulation Name | Urological catheter and accessories | Same | Same | | Regulation Number | 21 CFR 876.5130 | Same | Same | | Product Code | EZD | GBM | GBM | | Classification | II | Same | Same | | Parameter | Subject device | Predicate device | Reference device | | | Luja Coude | SpeediCath Flex Coudé Pro | SpeediCath Standard (male models only) | | Prescription Device | Yes | Same | Same | | Intended Use | Intermittent catheterization through the urethra. | Same | Same | | Condition of Use | Intermittent use and single use | Same | Same | | Drainage | Micro holes | Eyelets | Eyelets | | Device Categorization per ISO 10993 | Surface contacting device in contact with mucosal membrane for a prolonged duration of time (24 h < t< 30 days) | Same | Same | | Sterility | SAL 10-6 | Same | Same | | Sterilization Method | e-beam | Same | Same | | Shelf Life | 8 months at time of submission (planned 2 years) | 2 years | 2 years | | Available Sizes | Male, FR 8 / CH 8 Male, FR 10 / CH 10 Male, FR 12 / CH 12 Male, FR 14 / CH 14 Male, FR 16 / CH 16 | FR 10 / CH 10 FR 12 / CH 12 FR 14 / CH 14 FR 16 / CH 16 | Male, FR 8 / CH 8 Male, FR 10 / CH 10 Male, FR 12 / CH 12 Male, FR 14 / CH 14 Male, FR 16 / CH 16 Male, FR 18 / CH 18 Tiemann, FR 10 / CH 10 Tiemann, FR 12 / CH 12 Tiemann, FR 14 / CH 14 Tiemann, FR 16 / CH 16 | | Catheter Materials | Polyurethane | Same | Similar | | Hydrophilic Coating | Polyvinylpyrrolidone (PVP) based | Same | Same | | Swelling media (Wetting Agent) | Saline solution with PEG | Same | Same | | Tip Configuration | Flexible curved tip (bended) | Same | Straight (Nelaton) tip and Tiemann tip | | Protective Sleeve Material | Copoly (ethylene/octane) Copoly (isobutylene/styrene) | Same | N/A | | Inner Connector | Polyurethane White | Same | N/A no inner connector | | Parameter | Subject device | Predicate device | Reference device | | | Luja Coude | SpeediCath Flex Coudé Pro | SpeediCath Standard (male models only) | | Outer Connector material | Thermoplastic Polypropylene | Same with turquoise color | Thermoplastic polyurethane with masterbatches | | Handle material | Thermoplastic Polypropylene | Same with turquoise color | N/A | | Primary Packaging Description | Single and double-loop pouch packages, dark grey | Single and double-loop pouch packages, grey | Similar (longer and thicker), green | | Packaging Materials | Inner layer: PE-peel Outer layer: Printed PETP | Same | Oriented polyamide, aluminum, low-density polyethylene, ring-shaped opening feature | | Effective Catheter Length | Effective length (according to ISO 20696:2018): 33cm (13 inches) | Same | Effective length (according to ISO 20696:2018): 35cm (13.9 inches) | This file contains proprietary information and should not be disclosed without the consent of Coloplast. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a blue globe-like symbol on the left and the word "Coloplast" in blue, sans-serif font on the right. The globe symbol is made up of several horizontal lines that curve around to create a spherical shape. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Coloplast logo. The logo consists of a blue globe-like symbol on the left and the word "Coloplast" in blue, sans-serif font on the right. The globe symbol is made up of several horizontal lines that curve to form a sphere shape. ## Summary of Non-Clinical Performance Testing | Non-clinical test summary: | Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility: | ISO 10993-1 :2018, Biological evaluation of medical devices – Part 1: Evaluation of testing within a risk management process | | | ISO 10993-5 :2009, Biological evaluation of medical devices – Part 5: Test for in vitro cytotoxicity | | | ISO 10993-10 :2021, Biological evaluation of medical devices, Part 10: Test for irritation and skin sensitization | | | ISO 10993-11 :2017, Biological evaluation of medical devices, Part 11: Tests for systemic toxicity | | | ISO 10993-18 :2020, Biological evaluation of medical devices, Part 18: Chemical characterization of medical device materials within a risk management process | | | ISO 10993-23 :2021, Biological evaluation of medical devices, Part 23: Tests for irritation | | | The following biological endpoints were addressed: cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity. | | Catheter performance: | ISO 20696: 2018, Sterile urethral catheters for single use | | | ASTM F623-19, Standard performance specification for Foley Catheter | | | ASTM D1894: 2014, Standard test method for static and kinetic coefficients of friction of plastic film and sheeting | | | Coloplast Test Method TM 6058 Friction after 5 minutes | | | Coloplast Test Method TM 6059 opening torque | | | Coloplast Test Method TM 6100 sleeve collapse force | | | Coloplast Test Method TM6129: Kink and Coude measurement | | | EN/IEC 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices | This file contains proprietary information and should not be disclosed without the consent of Coloplast. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image contains the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue text on the right. The circular graphic is divided into two halves, with the top half containing several horizontal lines. Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. | Packaging: | ISO 11607-1 :2019, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ASTM F2096 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | | | EN 868-5 Packaging for terminally sterilized medical devices Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods | | | ASTM F88/FM88 Standard Test Method for Seal Strength of Flexible Barrier Materials. | | | ASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and Systems | | Packaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted 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. | | | Aging: | ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices | | The stability study investigated whether there were unexpected (significant) changes in product properties over | | the shelf-life of the device. The properties meet the acceptance criteria after the aging cycle, the device is therefore deemed to be stable for the defined shelf life. ### Conclusion The performance testing demonstrates the subject device is as safe and effective as the predicate device.