Mentor Self-Cath Plus
FDA 510(k) K003784 · Mentor Corp.
510(k) numberK003784
Submission
- Device name
- Mentor Self-Cath Plus
- Applicant
- Mentor Corp.
Santa Barbara, CA, US - Received
- December 7, 2000
- Decision date
- March 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| K062421 | Mentor Resterilizable Gel Breast Implant SizerMRD · Traditional | 10/10/2006SE |
| K053414 | Mentor Novasilk MeshOTP · Traditional | 12/27/2005SE |
| K053296 | Mentor Aris Suprapubic Surgical KitOTN · Traditional | 12/15/2005SE |
| K052440 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Special | 10/11/2005SE |
| K050008 | Mentor Self-Cath Hydrogel Intermittent CatheterEZD · Traditional | 06/03/2005SE |
| K050148 | Mentor Aris Trans-Obturator Tape and Surgical KitOTN · Traditional | 03/09/2005SE |
| K042851 | Mentor Obtape Trans-Obturator Surgical KitOTN · Special | 11/09/2004SE |
| K040959 | Mentor Genesis Penile ProsthesisFAE · Traditional | 10/29/2004SE |
| K031767 | Mentor Obtape Trans-Obturator TapeOTN · Traditional | 07/17/2003SE |
Questions and answers
When was Mentor Self-Cath Plus cleared by the FDA?
Mentor Self-Cath Plus (K003784) received a 510(k) decision of Substantially Equivalent on March 5, 2001, 88 days after the submission was received.
What is the product code of K003784?
The FDA product code is EZL – Catheter, Retention Type, Balloon, a Class II (moderate risk) device regulated under 21 CFR 876.5130.