Product code FCN
- Device name
- Urinary Drainage Collection Kit, For Indwelling Catheter
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5250
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951443 | STANDARD FOLEY SYSTEM PAK | Trinity Laboratories, Inc. | 1995-06-15 |
| K945258 | CATCO URINARY COLLECTION KIT | Catco Medical, Inc. | 1995-02-16 |
| K915166 | MICROCYCLER | Medical Inventors Corp., Inc. | 1994-09-07 |
| K922346 | FEMALE URINE SAMPLING DEVICE | Mentor Corp. | 1992-08-14 |
| K890096 | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG | Medical Inventors Corp., Inc. | 1989-07-14 |
| K883886 | DOUBLE CLOSED URINARY DRAINAGE SYSTEM | Knight Medical, Inc. | 1988-12-19 |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | Lake Medical Products, Inc. | 1988-10-12 |
| K780134 | URINARY DRAINAGE MONITORING SYSTEM | Medical Devices, Inc. | 1978-02-02 |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Kendall Research Center | 1977-11-28 |
| K771210 | UROGARD URINARY DRAINAGE BAG | Terumo America, Inc. | 1977-07-11 |
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| 10840330701775 | ProCure | Twin Med, LLC | 2025-05-31 |
| 10840330701768 | ProCure | Twin Med, LLC | 2025-05-31 |
| 10840330701751 | ProCure | Twin Med, LLC | 2025-05-31 |
| 10192253027686 | Dover | Cardinal Health 200, LLC | 2024-10-14 |
| 10192253065480 | Dover | Cardinal Health 200, LLC | 2024-09-03 |
| 10192253065497 | Dover | Cardinal Health 200, LLC | 2024-09-03 |
| 10192253065619 | Dover | Cardinal Health 200, LLC | 2024-09-03 |
| 10192253065626 | Dover | Cardinal Health 200, LLC | 2024-09-03 |
| 10192253051612 | Dover | Cardinal Health 200, LLC | 2024-08-08 |
| 10850053289108 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10850053289092 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10850053289085 | SURGYCO | Surgyco LLC | 2023-12-15 |
| 10193489198256 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-10-06 |
| 10193489191820 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-15 |
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| 10884521000285 | Dover | Cardinal Health, Inc. | 2016-09-24 |
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| 10884521001732 | Dover | Cardinal Health 200, LLC | 2016-09-24 |
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| 10884521029651 | Dover | Cardinal Health, Inc. | 2016-09-24 |
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| 10809160000670 | MEDICAL ACTION INDUSTRIES | MEDICAL ACTION INDUSTRIES INC. | 2016-08-24 |
| 10809160024812 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |
| 10809160026571 | Medical Action Industries | MEDICAL ACTION INDUSTRIES INC. | 2016-08-20 |