Female Urine Sampling Device
FDA 510(k) K922346 · Mentor Corp.
510(k) numberK922346
Submission
- Device name
- Female Urine Sampling Device
- Applicant
- Mentor Corp.
Santa Barbara, CA, US - Received
- May 19, 1992
- Decision date
- August 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCN – Urinary Drainage Collection Kit, For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951443 | Standard Foley System PakFCN · Traditional | Trinity Laboratories, Inc. | 06/15/1995SE |
| K945258 | Catco Urinary Collection KitFCN · Traditional | Catco Medical, Inc. | 02/16/1995SEKD |
| K915166 | MicrocyclerFCN · Traditional | Medical Inventors Corp., Inc. | 09/07/1994SE |
| K890096 | Bladder Cycler Closed-System Urinary Drain BagFCN · Traditional | Medical Inventors Corp., Inc. | 07/14/1989SE |
| K883886 | Double Closed Urinary Drainage SystemFCN · Traditional | Knight Medical, Inc. | 12/19/1988SE |
| K883610 | Lake Foley Catheterization TrayFCN · Traditional | Lake Medical Products, Inc. | 10/12/1988SE |
| K780134 | Urinary Drainage Monitoring SystemFCN · Traditional | Medical Devices, Inc. | 02/02/1978SE |
| K772133 | Urine Specimen Collecting DeviceFCN · Traditional | Kendall Research Center | 11/28/1977SE |
| K771210 | Urogard Urinary Drainage BagFCN · Traditional | Terumo America, Inc. | 07/11/1977SE |
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Questions and answers
When was Female Urine Sampling Device cleared by the FDA?
Female Urine Sampling Device (K922346) received a 510(k) decision of Substantially Equivalent on August 14, 1992, 87 days after the submission was received.
What is the product code of K922346?
The FDA product code is FCN – Urinary Drainage Collection Kit, For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.