Comfort Sleeved All Silicone Foley Catheter
FDA 510(k) K905042 · Rochester Medical Corp.
510(k) numberK905042
Submission
- Device name
- Comfort Sleeved All Silicone Foley Catheter
- Applicant
- Rochester Medical Corp.
Stewartville, MN, US - Received
- November 7, 1990
- Decision date
- January 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EZL – Catheter, Retention Type, Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260756 | TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)EZL · Traditional | Sentinel Medical Technologies, | 09/04/2026SE |
| K262056 | Rusch Latex Gold Foley CatheterEZL · Traditional | Teleflex Medical Sdn. Bhd. | 08/05/2026SE |
| K252537 | Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflex Medical Sdn. Bhd. | 01/20/2026SE |
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter)EZL · Traditional | Guangdong Ecan Medical Co., Ltd. | 06/16/2025SE |
| K241424 | InnoCare Specialty Foley CatheterEZL · Traditional | Innocare Urologics, LLC | 09/18/2024SE |
| K232469 | Rüsch Latex Gold Foley CatheterEZL · Traditional | Teleflexmedical, Inc. | 08/01/2024SE |
| K240057 | TraumaGuard Intra-abdominal Pressure Sensing SystemEZL · Traditional | Sentinel Medical Technologies, LLC | 04/17/2024SE |
| K233411 | Folysil Silicone CatheterEZL · Traditional | Coloplast Corp. | 04/15/2024SE |
| K233013 | 2-Way 100% Silicone Cleartract CatheterEZL · Traditional | Silq Technologies Corporation | 01/23/2024SE |
| K212077 | Teleflex Rusch SoftSimplastic Foley CathetersEZL · Traditional | Teleflexmedical, Inc. | 07/27/2023SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K122785 | Hydrosil; Magic; Personal CatheterEZD · Traditional | 05/14/2013SE |
| 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 |
Questions and answers
When was Comfort Sleeved All Silicone Foley Catheter cleared by the FDA?
Comfort Sleeved All Silicone Foley Catheter (K905042) received a 510(k) decision of Substantially Equivalent on January 18, 1991, 72 days after the submission was received.
What is the product code of K905042?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.