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troCarWash™ System

by Biotex, Inc. 2 variants

510(k) K222695

troCarWash System is a medical device (FDA Class II; FDA product code OCX, Endoscopic Irrigation/Suction System) made by Biotex, Inc., cleared under FDA 510(k) K222695 on 17 Feb 2023, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK222695 Date17 Feb 2023ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OCX
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K222695

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K222695
UDI-DISize and differences
Bayou™ troCarWash System Controller 038-5000
BIOTEX, INC.
038-5000M71003850000
Single use: no
No longer on the market
Bayou™ troCarWash System Disposable Kit 038-1000
BIOTEX, INC.
038-1000M71003810000
Single use: yes
No longer on the market

Similar devices

Other devices filed under FDA product code OCX (Endoscopic Irrigation/Suction System).

Other devices from Biotex, Inc.

See all devices from Biotex, Inc. →