troCarWash System— 510(k) K233442

Substantially Equivalent

Biotex, Inc.

FDA 510(k) clearance K233442 for troCarWash System, Substantially Equivalent on 2024-05-21. Applicant: Biotex, Inc.. Device class: 2.

Clearance details

Applicant: Biotex, Inc.
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-10-18
Decision date: 2024-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.