Model 20C W/an Ar-10A/U & Rl-20A/U for Arthroscop.

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K880216 ↗

FDA Product Code

GEX

Models / Variants

20C W

An Ar-10A

U

Rl-20A

U For Arthroscop.

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Model 20-Ch W/ Ar-10A/U Optical Attachment

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See all devices from Directed Energy, Inc. →

• What is the MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. used for?

  This device is an arthroscopic instrument system designed for use in arthroscopic procedures, with indications for general and plastic surgery applications as determined by its advisory committee classification under product code GEX.

• How is the MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. supplied and is it reusable?

  The device is supplied as a reusable instrument system for arthroscopic use, meaning it is intended to be cleaned, sterilized, and reused multiple times following appropriate reprocessing protocols.

• What regulatory pathway was used for the MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.?

  The device was cleared through the FDA 510(k) process under submission K880216 using a traditional clearance pathway and was found substantially equivalent to a predicate device.