Cleared Traditional

troCarWash™ System (K233442) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233442 · Biotex, Inc. · General & Plastic Surgery device
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May 2024
Decision
216d
Days
Class 2
Risk

K233442 is an FDA 510(k) clearance for the troCarWash™ System. Classified as Endoscopic Irrigation/suction System (product code OCX), Class II - Special Controls.

Submitted by Biotex, Inc. (Houston, US). The FDA issued a Cleared decision on May 21, 2024 after a review of 216 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Biotex, Inc. devices

Submission Details

510(k) Number K233442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2023
Decision Date May 21, 2024
Days to Decision 216 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 115d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCX Endoscopic Irrigation/suction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OCX Endoscopic Irrigation/suction System

All 46
Devices cleared under the same product code (OCX) and FDA review panel - the closest regulatory comparables to K233442.
Water Container (MAJ-901)
K242357 · Olympus Medical Systems Corporation · Oct 2024
Aspiration Catheter (2189)
K241874 · Hobbs Medical, Inc. · Sep 2024
ClearCap Distal Attachment
K242134 · Finemedix Co., Ltd. · Aug 2024
Endoscopy Irrigation Tubing
K230773 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Nov 2023
Air/Water Bottle Tubing, CO2 Source Tubing
K231471 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Sep 2023
ENDOGATOR™ Hybrid Irrigation Tubing
K231418 · Medivators · Aug 2023