troCarWash System
FDA 510(k) K233442 · Biotex, Inc.
510(k) numberK233442
Submission
- Device name
- troCarWash System
- Applicant
- Biotex, Inc.
Houston, TX, US - Received
- October 18, 2023
- Decision date
- May 21, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCX – Endoscopic Irrigation/Suction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
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|---|---|---|---|
| K251986 | Auxiliary Water Tube MAJ-855OCX · Traditional | Olympus Medical Systems Corporation | 09/26/2025SE |
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| K242586 | ArgoCap (200.52)OCX · Traditional | Ovesco Endoscopy AG | 05/22/2025SE |
| K241704 | Endoscopic Water PumpOCX · Traditional | Hangzhou AGS MedTech Co., Ltd. | 03/20/2025SE |
| K242357 | Water Container (MAJ-901); Water Container (MAJ-902)OCX · Traditional | Olympus Medical Systems Corporation | 10/07/2024SE |
| K241874 | Aspiration Catheter (2189)OCX · Traditional | Hobbs Medical, Inc. | 09/24/2024SE |
| K242134 | ClearCap Distal AttachmentOCX · Special | Finemedix Co., Ltd. | 08/20/2024SE |
| K230773 | Endoscopy Irrigation TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 11/21/2023SE |
| K231471 | Air/Water Bottle Tubing, CO2 Source TubingOCX · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 09/08/2023SE |
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | Medivators | 08/14/2023SE |
More from Medivators
| 510(k) | Device | Decision |
|---|---|---|
| K222695 | troCarWash SystemOCX · Traditional | 02/17/2023SE |
| K203712 | The SlideLQZ · Traditional | 07/20/2021SE |
| K161704 | Phasor DrillHBE · Traditional | 12/01/2016SE |
| K092197 | PHOTEX30 Diode Laser Series: 980, 810, 940GEX · Traditional | 10/06/2009SE |
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| K071328 | Visualase Thermal Therapy SystemGEX · Traditional | 08/31/2007SE |
| K063505 | Visualase Envision Software SystemLLZ · Traditional | 12/12/2006SE |
| K060304 | Photex Diode Laser Series, Models 980, 810 and 940GEX · Traditional | 03/21/2006SE |
| K053087 | Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemGEX · Traditional | 03/01/2006SE |
Questions and answers
When was troCarWash System cleared by the FDA?
troCarWash System (K233442) received a 510(k) decision of Substantially Equivalent on May 21, 2024, 216 days after the submission was received.
What is the product code of K233442?
The FDA product code is OCX – Endoscopic Irrigation/Suction System, a Class II (moderate risk) device regulated under 21 CFR 876.1500.