Product code FCM
- Device name
- Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5130
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250891 | Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic C... | Convatec Limited | 2025-06-06 |
| K223821 | Self-Cath Closed System | Coloplast | 2023-08-02 |
| K082831 | AMSELF CLOSED CATHETERIZATION SYSTEM | Amsino International, Inc. | 2008-10-23 |
| K070939 | SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM | Coloplast Manufacturing Us, LLC | 2007-06-01 |
| K070048 | GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT | Marian Medical, Inc. | 2007-03-15 |
| K030664 | AMSURE FOLEY INSERTION TRAY | Amsino International, Inc. | 2003-05-23 |
| K030712 | AMSURE URETHRAL CATHETERIZATION TRAY | Amsino International, Inc. | 2003-05-23 |
| K011055 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS | Go Medical Industries Pty. , Ltd. | 2001-06-06 |
| K010420 | RUSCH MMG/O'NEIL CATHETER | Rusch, Inc. | 2001-05-09 |
| K003873 | MENTOR SELF-CATH CLOSED SYSTEM | Mentor Corp. | 2001-03-29 |
| K002803 | THE O'NEIL STERILE FIELD URINARY CATHETER KIT | Go Medical Industries Pty. , Ltd. | 2000-12-27 |
| K983010 | SELF CATH SET/SAFETY CATH | Rusch Intl. | 1999-02-12 |
| K963993 | RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET | Rusch, Inc. | 1996-12-17 |
| K962254 | NHMC URETHRAL CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-07-29 |
| K962073 | URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY | Continental Medical Laboratories, Inc. | 1996-06-21 |
| K961442 | UNIVERSAL DRAINAGE TRAY | Customed, Inc. | 1996-05-09 |
| K960215 | CPR URETHRAL CATHETER TRAY | Custom Pack Reliability | 1996-04-01 |
| K960214 | CPR FOLEY CAHTETER KIT | Custom Pack Reliability | 1996-04-01 |
| K960566 | NHMC FOLEY CATHETERIZATION TRAY | National Healthcare Mfg. Corp. | 1996-02-29 |
| K951479 | CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE | Trinity Laboratories, Inc. | 1995-06-15 |
| K950390 | URETHRAL CATHETERIZATION TRAY | Medcare Custom Packaging, Inc. | 1995-05-30 |
| K951178 | UROLOGICAL CATHETER & ACCESSORIES | Deroyal Industries, Inc. | 1995-04-21 |
| K950344 | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER | Acacia Laboratories, Inc. | 1995-03-24 |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | Cypress Medical Products, Ltd. | 1995-02-27 |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | Cypress Medical Products, Ltd. | 1995-02-27 |
| K942177 | FOLEY CATHETERIZATION TRAY | Customed, Inc. | 1994-09-08 |
| K923538 | MON-A-THERM FOLEY KIT | Mallinckrodt Medical | 1993-05-27 |
| K910653 | TOUCHLESS II INTERMITTENT CATHETER | C.R. Bard, Inc. | 1991-05-06 |
| K910022 | MMG/O'NEIL URINARY CATHETERIZATION SYSTEM KIT | Medical Marketing Group | 1991-04-02 |
| K904158 | ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY | Welcon, Inc. | 1990-11-29 |
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| 10192253030174 | Dover | Cardinal Health 200, LLC | 2025-10-17 |
| 10192253028942 | Dover | Cardinal Health 200, LLC | 2025-09-16 |
| 10192253028935 | Dover | Cardinal Health 200, LLC | 2025-09-16 |
| 10192253028393 | Dover | Cardinal Health 200, LLC | 2025-05-16 |
| 10192253028904 | Dover | Cardinal Health 200, LLC | 2025-05-14 |
| 10192253028003 | Dover | Cardinal Health 200, LLC | 2025-05-14 |
| 10192253028140 | Dover | Cardinal Health 200, LLC | 2025-03-20 |
| 10192253030198 | Dover | Cardinal Health 200, LLC | 2025-03-20 |
| 10192253028928 | Dover | Cardinal Health 200, LLC | 2025-03-20 |
| 10192253028911 | Dover | Cardinal Health 200, LLC | 2025-03-20 |
| 10192253028010 | Dover | Cardinal Health 200, LLC | 2025-03-20 |
| 10192253027785 | Dover | Cardinal Health 200, LLC | 2025-03-20 |
| 10192253027914 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027884 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028553 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027877 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027853 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028850 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028874 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253028881 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027846 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027839 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027808 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027778 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10192253027693 | Dover | Cardinal Health 200, LLC | 2024-12-20 |
| 10080196509607 | Medline | MEDLINE INDUSTRIES, INC. | 2021-09-22 |
| 10080196324620 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |