Hydrosil; Magic; Personal Catheter
FDA 510(k) K122785 · Rochester Medical Corp.
510(k) numberK122785
Submission
- Device name
- Hydrosil; Magic; Personal Catheter
- Applicant
- Rochester Medical Corp.
Stewartville, MN, US - Received
- September 11, 2012
- Decision date
- May 14, 2013
- 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 |
More from Jamjoom Fullcare Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitMJC · Traditional | 06/10/2004SE |
| K001143 | Release NF Antibacterial Foley Catheter, Antibacterial Personal CatheterMJC · Traditional | 07/07/2000SE |
| K000723 | Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and…KOD · Traditional | 05/19/2000SE |
| K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…EZL · Traditional | 07/08/1998SE |
| K971627 | Silicone Antibacterial Foley CatheterMJC · Traditional | 01/13/1998SE |
| K970704 | Personal CatheterGBM · Traditional | 03/13/1997SE |
| K952082 | Rochester Medical Corporation Silicone Male External CatheterEXJ · Traditional | 07/18/1995SE |
| K941692 | Female Length All Silicone Urological CatheterEZL · Traditional | 03/06/1995SE |
| K943851 | All Silicone Intermittent CatheterGBM · Traditional | 01/31/1995SE |
| K923136 | Male External CatheterEXJ · Traditional | 12/03/1992SE |
Questions and answers
When was Hydrosil; Magic; Personal Catheter cleared by the FDA?
Hydrosil; Magic; Personal Catheter (K122785) received a 510(k) decision of Substantially Equivalent on May 14, 2013, 245 days after the submission was received.
What is the product code of K122785?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.