Open Ended Ureteral Catheter
FDA 510(k) K830840 · Van-Tec, Inc.
510(k) numberK830840
Submission
- Device name
- Open Ended Ureteral Catheter
- Applicant
- Van-Tec, Inc.
Mchenry, IL, US - Received
- March 16, 1983
- Decision date
- April 6, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | Well Lead Medical Co., Ltd. | 03/05/2025SE |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
More from Hollister Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K880099 | Van-Tec Bladder EvacuatorKQT · Traditional | 03/02/1988SE |
| K880098 | Van-Tec Auto Biopsy NeedleKNW · Traditional | 03/02/1988SE |
| K880096 | Van-Tec Aspiration Biopsy System W/Collection CupKNW · Traditional | 03/02/1988SE |
| K880095 | Berger Prostate Culture Cytology BrushFDX · Traditional | 03/02/1988SE |
| K880094 | Van-Tec Endopyelotomy KnifeEMF · Traditional | 02/29/1988SE |
| K874112 | Van-Tec Double Occlusion Balloon CatheterKOD · Traditional | 02/11/1988SE |
| K871779 | Helical Stone Basket (Disposable)FFL · Traditional | 06/17/1987SE |
| K871777 | Van-Tec Reusable Helical Stone BasketFFL · Traditional | 06/17/1987SE |
| K870696 | Van-Tec Segura Stone Basket W/Protective SheathFFL · Traditional | 03/30/1987SE |
| K870679 | Van-Tec Modular Flexible CystourethroscopeFBO · Traditional | 03/30/1987SE |
Questions and answers
When was Open Ended Ureteral Catheter cleared by the FDA?
Open Ended Ureteral Catheter (K830840) received a 510(k) decision of Substantially Equivalent on April 6, 1983, 21 days after the submission was received.
What is the product code of K830840?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.