DOUBLE CLOSED URINARY DRAINAGE SYSTEM
FDA 510(k) clearance K883886 · decided 1988-12-19
Clearance details
- K-number
- K883886
- Device name
- DOUBLE CLOSED URINARY DRAINAGE SYSTEM
- Applicant
- Knight Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-13
- Decision date
- 1988-12-19
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- FCN
- Device class
- 2
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STANDARD FOLEY SYSTEM PAK (K951443) | Trinity Laboratories, Inc. | 1995-06-15 |
| CATCO URINARY COLLECTION KIT (K945258) | Catco Medical, Inc. | 1995-02-16 |
| MICROCYCLER (K915166) | Medical Inventors Corp., Inc. | 1994-09-07 |
| FEMALE URINE SAMPLING DEVICE (K922346) | Mentor Corp. | 1992-08-14 |
| BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG (K890096) | Medical Inventors Corp., Inc. | 1989-07-14 |
| LAKE FOLEY CATHETERIZATION TRAY (K883610) | Lake Medical Products, Inc. | 1988-10-12 |
| URINARY DRAINAGE MONITORING SYSTEM (K780134) | Medical Devices, Inc. | 1978-02-02 |
| URINE SPECIMEN COLLECTING DEVICE (K772133) | Kendall Research Center | 1977-11-28 |
| UROGARD URINARY DRAINAGE BAG (K771210) | Terumo America, Inc. | 1977-07-11 |
Recalls involving this device
No recalls on record reference this clearance.