Mentor Self-Cath Closed System
FDA 510(k) K003873 · Mentor Corp.
510(k) numberK003873
Submission
- Device name
- Mentor Self-Cath Closed System
- Applicant
- Mentor Corp.
Santa Barbara, CA, US - Received
- December 15, 2000
- Decision date
- March 29, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter KitFCM · Traditional | C.R. Bard, Inc. | 05/29/2026SESK |
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter…FCM · Special | Convatec Limited | 06/06/2025SESK |
| K223821 | Self-Cath Closed SystemFCM · Traditional | Coloplast | 08/02/2023SE |
| K082831 | Amself Closed Catheterization SystemFCM · Special | Amsino International, Inc. | 10/23/2008SE |
| K070939 | Self-Cath CS Closed Urinary Catheterization SystemFCM · Special | Coloplast Manufacturing Us, LLC | 06/01/2007SE |
| K070048 | Guardian Catheter-Infant Urinary Collection KitFCM · Traditional | Marian Medical, Inc. | 03/15/2007SE |
| K030712 | Amsure Urethral Catheterization TrayFCM · Traditional | Amsino International, Inc. | 05/23/2003SE |
| K030664 | Amsure Foley Insertion TrayFCM · Traditional | Amsino International, Inc. | 05/23/2003SE |
| K011055 | The O'Neil Sterile Field Urinary Catheter Kit with Prep PadsFCM · Traditional | Go Medical Industries Pty. , Ltd. | 06/06/2001SE |
| K010420 | Rusch Mmg/O'Neil CatheterFCM · Traditional | Rusch, Inc. | 05/09/2001SE |
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| K130813 | Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue…LCJ · Special | 04/11/2013SE |
| 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 Closed System cleared by the FDA?
Mentor Self-Cath Closed System (K003873) received a 510(k) decision of Substantially Equivalent on March 29, 2001, 104 days after the submission was received.
What is the product code of K003873?
The FDA product code is FCM – Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), a Class II (moderate risk) device regulated under 21 CFR 876.5130.