Dynarex Intermittent Catheters, Male, Female, Pediatric
FDA 510(k) K103086 · Dynarex Corporation
510(k) numberK103086
Submission
- Device name
- Dynarex Intermittent Catheters, Male, Female, Pediatric
- Applicant
- Dynarex Corporation
Orangeburg, NY, US - Received
- October 19, 2010
- Decision date
- June 7, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZD – Catheter, Straight
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | Convatec | 08/05/2026SE |
| K261658 | LoFric Origo Pro CoudéEZD · Special | Wellspect AB | 07/17/2026SE |
| K262045 | Luja SoftEZD · Special | Coloplast A.S. | 07/07/2026SE |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZD · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/24/2026SE |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | Hollister Incorporated | 05/18/2026SE |
| K260999 | LoFric Elle ProEZD · Special | Wellspect AB | 04/24/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | Convatec Limited | 04/01/2026SE |
| K260502 | Liv Pre-lubricated Intermittent CatheterEZD · Traditional | HR Healthcare | 03/12/2026SE |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…EZD · Traditional | HR Healthcare | 01/29/2026SESK |
| K251178 | Ready to use Nelaton CatheterEZD · Traditional | Jamjoom Fullcare Corporation | 01/02/2026SE |
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| K151575 | Dynarex Eye CupsLXQ · Traditional | 09/01/2015SE |
| K102637 | Dynarex Ultrasound GelMUI · Traditional | 02/16/2011SE |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | 12/18/2009SE |
| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…KNT · Traditional | 01/09/2009SE |
| K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with…LZA · Abbreviated | 09/12/2008SE |
| K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921CBP · Traditional | 12/22/2005SE |
| K052314 | Dynarex Vaginal Specula 4900, Models 4911-SMALL, 4912-MEDIUM, 4913-LARGEHIB · Traditional | 11/09/2005SE |
| K012816 | Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414FRO · Traditional | 10/17/2002SE |
Questions and answers
When was Dynarex Intermittent Catheters, Male, Female, Pediatric cleared by the FDA?
Dynarex Intermittent Catheters, Male, Female, Pediatric (K103086) received a 510(k) decision of Substantially Equivalent on June 7, 2011, 231 days after the submission was received.
What is the product code of K103086?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.