Rusch Mmg/O'Neil Catheter
FDA 510(k) K010420 · Rusch, Inc.
510(k) numberK010420
Submission
- Device name
- Rusch Mmg/O'Neil Catheter
- Applicant
- Rusch, Inc.
Duluth, GA, US - Received
- February 12, 2001
- Decision date
- May 9, 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
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 |
| K003873 | Mentor Self-Cath Closed SystemFCM · Traditional | Mentor Corp. | 03/29/2001SE |
More from Mentor Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K993528 | Rusch Emergency MaskCBP · Traditional | 05/31/2000SE |
| K993194 | Rusch Manual Resuscitator BagBTM · Traditional | 03/24/2000SE |
| K980870 | Rusch Silicone Foley CatheterEZL · Traditional | 06/09/1998SE |
| K974419 | Rusch Simplastic Councill Tip CatheterEZL · Traditional | 01/27/1998SE |
| K963779 | Rusch Enteral Feeding TubeFPD · Traditional | 05/23/1997SE |
| K970021 | Rusch Suprapubic TrayKOB · Traditional | 02/07/1997SE |
| K963993 | Rusch Simplastic Foley Catheterization SetFCM · Traditional | 12/17/1996SE |
| K955564 | Rusch Ultra Tracheoflex Tracheostomy Set, Cuffed, SterileJOH · Traditional | 06/28/1996SE |
| K955495 | Rusch Reinforced Trachael Tube Cuffed, SterileBTR · Traditional | 06/27/1996SE |
| K953963 | Rusch Single Lumen Bronchial Tuvbe Set, Sterile, for Left & Right Sided Bronchial…BTS · Traditional | 11/27/1995SE |
Questions and answers
When was Rusch Mmg/O'Neil Catheter cleared by the FDA?
Rusch Mmg/O'Neil Catheter (K010420) received a 510(k) decision of Substantially Equivalent on May 9, 2001, 86 days after the submission was received.
What is the product code of K010420?
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.