Data / Medical devices / United States / Biotex, Inc.
Biotex, Inc.: FDA-registered device maker in Houston, TX, United States, 2 510(k) clearances
Biotex, Inc. is registered with the FDA (registration 3005726841) in Houston, TX, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005726841
- Address
- 114 Holmes Rd, Houston, TX, United States, 77045
- Owner or operator
- BIOTEX, INC. (9079181)
- Roles
- Manufacturer
- First device listed
- June 27, 2019
- Registered through
- 2026
- Brand names listed
- Slide Bite Fork, SurgiLux, The Slide, Wire Watch, troCarWash Automated Visualization System, troCarWash System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Catheter | KGZ | 1 | Manufacturer | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Manufacturer | accessdata.fda.gov |
| Lamp, Surgical | FTD | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2024 | K233442 | troCarWash System | OCX | Substantially Equivalent | Biotex, Inc. | accessdata.fda.gov |
| July 20, 2021 | K203712 | The Slide | LQZ | Substantially Equivalent | Biotex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Irrigation/Suction System
- All makers of Pump, Air, Non-Manual, For Endoscope
- All makers of Accessories, Catheter
- All makers of Lamp, Surgical
- All makers of Tray, Impression, Preformed
- All makers of Device, Jaw Repositioning
Updated May 21, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.