FDA Product Code
FDA Product Code FCN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5250
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K951443 | STANDARD FOLEY SYSTEM PAK | Trinity Laboratories, Inc. | 1995-06-15 | Traditional | PDF ↗ |
| K945258 | CATCO URINARY COLLECTION KIT | Catco Medical, Inc. | 1995-02-16 | Traditional | PDF ↗ |
| K915166 | MICROCYCLER | Medical Inventors Corp., Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K922346 | FEMALE URINE SAMPLING DEVICE | Mentor Corp. | 1992-08-14 | Traditional | PDF ↗ |
| K890096 | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG | Medical Inventors Corp., Inc. | 1989-07-14 | Traditional | PDF ↗ |
| K883886 | DOUBLE CLOSED URINARY DRAINAGE SYSTEM | Knight Medical, Inc. | 1988-12-19 | Traditional | PDF ↗ |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | Lake Medical Products, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K780134 | URINARY DRAINAGE MONITORING SYSTEM | Medical Devices, Inc. | 1978-02-02 | Traditional | PDF ↗ |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Kendall Research Center | 1977-11-28 | Traditional | PDF ↗ |
| K771210 | UROGARD URINARY DRAINAGE BAG | Terumo America, Inc. | 1977-07-11 | Traditional | PDF ↗ |
Product code FCN · Class II · Gastroenterology, Urology. Data: openFDA.