FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
troCarWash System
K Number: K222695
·
Decision Feb 17, 2023
Classifications
1
FEI Numbers
98
Registration Numbers
98
Same Product Code
92
Applicant Total
10
Review Days
164
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Basic Information
- Device Name
- troCarWash System
- K Number
- K222695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biotex, Inc.
- Date Received
- September 6, 2022
- Decision Date
- February 17, 2023
- Product Code
- OCX
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Biotex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K233442 | troCarWash System | May 21, 2024 | Substantially Equivalent |
| K203712 | The Slide | Jul 20, 2021 | Substantially Equivalent |
| K161704 | Phasor Drill | Dec 1, 2016 | Substantially Equivalent |
| K092197 | PHOTEX30 DIODE LASER SERIES: 980, 810, 940 | Oct 6, 2009 | Substantially Equivalent |
| K081656 | VISUALASE THERMAL THERAPY SYSTEM | Sep 10, 2008 | Substantially Equivalent |
| K071328 | VISUALASE THERMAL THERAPY SYSTEM | Aug 31, 2007 | Substantially Equivalent |
| K063505 | VISUALASE ENVISION SOFTWARE SYSTEM | Dec 12, 2006 | Substantially Equivalent |
| K060304 | PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 | Mar 21, 2006 | Substantially Equivalent |
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM | Mar 1, 2006 | Substantially Equivalent |