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Dyonics Control Rf System

by Smith & Nephew, Inc.

510(k) K003572

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003572 Date15 Feb 2001ClearedStatusActive

Recalls

0 recalls · FDA

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

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  • Withdrawn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
HRX
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The DYONICS CONTROL RF SYSTEM is a Class II medical device classified under product code HRX, designed for use in orthopedic procedures.

The device was cleared by the FDA through the 510(k) process under submission K003572 on February 15, 2001, following a traditional review. It is manufactured by Smith & Nephew, Inc. and is intended for use in arthroscopic applications as defined by its regulatory classification.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DYONICS CONTROL RF SYSTEM used for?

    The DYONICS CONTROL RF SYSTEM is an electrically powered arthroscope intended to visualize the interior of a joint during orthopedic procedures, as defined by its HRX product code classification for orthopedic applications.

  • How was the DYONICS CONTROL RF SYSTEM cleared for market?

    The device received FDA 510(k) clearance through submission K003572 on February 15, 2001, following a traditional review process, and was determined to be substantially equivalent to a predicate device.

  • Who manufactures the DYONICS CONTROL RF SYSTEM and where is it located?

    The DYONICS CONTROL RF SYSTEM is manufactured by Smith & Nephew, Inc., located at 160 Dascomb Rd., Andover, MA 01810, United States, as listed in the device authorization records.