Foley Insertion Tray
FDA 510(k) K923906 · Kit Pak, Inc.
510(k) numberK923906
Submission
- Device name
- Foley Insertion Tray
- Applicant
- Kit Pak, Inc.
Elk Grove Village, IL, US - Received
- August 4, 1992
- Decision date
- June 22, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K251864 | Rubber Utility CatheterKOD · Traditional | C.R. Bard, Inc. | 02/23/2026SE |
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| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD · Traditional | Urogen Pharma, Ltd. | 11/19/2021SE |
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| K180354 | UroGen Ureteral CatheterKOD · Traditional | Urogen Pharma, Ltd. | 10/30/2018SE |
| K181144 | Angled Tip Ureteral CatheterKOD · Traditional | Cook Incorporated | 06/28/2018SE |
| K180530 | Imager II Urology Torque CatheterKOD · Special | Boston Scientific Corporation | 04/10/2018SE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional | Cook Incorporated | 03/07/2018SE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional | Cook Incorporated | 02/16/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K942959 | Kit Pak Wet Saline DressingFRO · Traditional | 02/14/1995SN |
| K941499 | Kit Pak Dressing Change TrayKGX · Traditional | 07/20/1994SEKD |
| K932310 | Kit Pak Incontinent Skin Care KitEYQ · Traditional | 06/01/1994SEKD |
| K934080 | Urinary Drainage BagEYT · Traditional | 05/18/1994SE |
| K931013 | Foley Catheter TrayKNY · Traditional | 08/09/1993SE |
| K923905 | Wound Dressing KitMCY · Traditional | 07/02/1993SEKD |
| K924051 | Kit Pak I.V. Start KitLYY · Traditional | 06/22/1993SEKD |
| K922051 | Kit Pak's Flushing KitKOD · Traditional | 06/17/1993SESK |
| K925281 | Kit Pak Urinary Care SuppliesKNY · Traditional | 04/19/1993SESK |
| K900148 | Kit Pak Irrigation TrayEYN · Traditional | 04/23/1990SEKD |
Questions and answers
When was Foley Insertion Tray cleared by the FDA?
Foley Insertion Tray (K923906) received a 510(k) decision of Unknown on June 22, 1993, 322 days after the submission was received.
What is the product code of K923906?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.