Actreen Hi-Lite Cath, Actreen Hi-Lite Set
FDA 510(k) K180801 · B.Braun Medical, Inc.
510(k) numberK180801
Submission
- Device name
- Actreen Hi-Lite Cath, Actreen Hi-Lite Set
- Applicant
- B.Braun Medical, Inc.
Allentown, PA, US - Received
- March 28, 2018
- Decision date
- November 5, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K254111 | Irrigation/Urology SetsLJH · Traditional | 09/10/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | 05/15/2026SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | 07/24/2025SE |
| K240578 | VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemDTK · Traditional | 07/31/2024SE |
| K241845 | Introcan Safety® 2 IV CatheterFOZ · Special | 07/26/2024SE |
| K241385 | Omnifix Syringe NRFitQEH · Traditional | 07/13/2024SE |
| K231242 | Perifix FX Catheter; Contiplex FX CatheterBSO · Traditional | 09/15/2023SE |
| K223479 | AQUAbase nXFIP · Traditional | 08/16/2023SE |
| K220756 | Introcan Safety 2 IV CatheterFOZ · Special | 06/23/2022SE |
| K220626 | Introcan Safety IV CatheterFOZ · Special | 05/14/2022SE |
Questions and answers
When was Actreen Hi-Lite Cath, Actreen Hi-Lite Set cleared by the FDA?
Actreen Hi-Lite Cath, Actreen Hi-Lite Set (K180801) received a 510(k) decision of Substantially Equivalent on November 5, 2018, 222 days after the submission was received.
What is the product code of K180801?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.