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Arthroscopic Instruments

by Arthrex, Inc.

510(k) K925456

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 NumberK925456 Date4 Mar 1993ClearedStatusActive

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  • Withdrawn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, 24 Sep 2026

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

Arthroscopic Instruments are devices used in arthroscopic surgery, a minimally invasive orthopedic procedure. They are designed for use in joint visualization and treatment.

These instruments are supplied by Arthrex, Inc. and were cleared through the FDA 510(k) process under K925456 with product code HRX. They are intended for use in orthopedic surgical settings as substantially equivalent to previously cleared devices.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 24 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 are Arthroscopic Instruments used for?

    Arthroscopic Instruments are used in arthroscopic surgery, a minimally invasive orthopedic procedure, for joint visualization and treatment as stated in the device description.

  • How are Arthroscopic Instruments supplied and cleared for use?

    These instruments are supplied by Arthrex, Inc. and were cleared through the FDA 510(k) process under K925456 with product code HRX as substantially equivalent to previously cleared devices.

  • What regulatory pathway was used for Arthroscopic Instruments?

    Arthroscopic Instruments received clearance via the traditional FDA 510(k) pathway, as indicated by the clearance_type field showing 'Traditional' and decision_code 'SESE' for substantially equivalent determination.