Urethral Catheterization Tray
FDA 510(k) K950390 · Medcare Custom Packaging, Inc.
510(k) numberK950390
Submission
- Device name
- Urethral Catheterization Tray
- Applicant
- Medcare Custom Packaging, Inc.
East Swanzey, NH, US - Received
- February 1, 1995
- Decision date
- May 30, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code FCM
| 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 |
More from Rusch, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954869 | Medcare Yankauer Suction DeviceGCX · Traditional | 01/19/1996SE |
| K954442 | Sterile Isotonic Saline & Sterile WaterJOL · Traditional | 12/21/1995SE |
| K952759 | Towel PackKKX · Traditional | 09/29/1995SE |
| K943661 | Sterile Physiological Saline/Sterile WaterJOL · Traditional | 04/10/1995SE |
| K951149 | Single Use Instrument TrayLRO · Traditional | 04/06/1995SESK |
| K934732 | Pelvic Exam TrayHHT · Traditional | 12/30/1994SE |
| K942000 | Burn Dressing TrayFRG · Traditional | 05/20/1994SESK |
| K936261 | Catheter Insertion TrayFMI · Traditional | 03/10/1994SESK |
| K922179 | Catheter Insertion TrayFMI · Traditional | 07/02/1993SEKD |
| K901856 | Custom Wound Management Kits and TraysLRO · Traditional | 08/01/1990SESD |
Questions and answers
When was Urethral Catheterization Tray cleared by the FDA?
Urethral Catheterization Tray (K950390) received a 510(k) decision of Substantially Equivalent on May 30, 1995, 118 days after the submission was received.
What is the product code of K950390?
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.