Conphar Silicone Coated Foley Cath
FDA 510(k) K792111 · Conphar, Inc.
510(k) numberK792111
Submission
- Device name
- Conphar Silicone Coated Foley Cath
- Applicant
- Conphar, Inc.
Mchenry, IL, US - Received
- October 25, 1979
- Decision date
- November 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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|---|---|---|
| K821825 | Conphar Silicone Feeding TubeKNT · Traditional | 08/10/1982SE |
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| K821295 | Olsen Hegar Needle HoldersGDF · Traditional | 06/03/1982SE |
| K821289 | Mayo-Hegar Needle HolderGDF · Traditional | 06/03/1982SE |
| K821298 | Backhaus Clamp, 3 1/2HTD · Traditional | 05/28/1982SE |
| K821294 | Tonsil Scissors Straight 5 1/2EGN · Traditional | 05/28/1982SE |
| K821293 | Backhaus Clamp, 5 1/4HTD · Traditional | 05/28/1982SE |
| K821292 | Tonsil Scissors 7EGN · Traditional | 05/28/1982SE |
| K821290 | Littauer Scissors 5 1/2HNF · Traditional | 05/28/1982SE |
| K821286 | Iris Scissors Straight 4 1/2HNF · Traditional | 05/28/1982SE |
Questions and answers
When was Conphar Silicone Coated Foley Cath cleared by the FDA?
Conphar Silicone Coated Foley Cath (K792111) received a 510(k) decision of Substantially Equivalent on November 16, 1979, 22 days after the submission was received.
What is the product code of K792111?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.