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Arthroscopes & Associated Instruments

by Downs Surgical, Ltd. 510(k)

Active United States

510(k) K821359

Overview

The Arthroscopes & Associated Instruments are a type of orthopedic device, substantially equivalent to other devices on the market. They are used in surgical procedures to visualize and diagnose conditions within joints. The device is classified under the product code HRX. The Arthroscopes & Associated Instruments are designed to provide a clear view of the joint, allowing for accurate diagnosis and treatment.

The Arthroscopes & Associated Instruments are supplied by Downs Surgical, Ltd. and have been cleared by the FDA under the traditional 510(k) clearance process, with the clearance number K821359. The device is intended for use in a surgical setting and is subject to the regulations and guidelines set forth by the FDA. The Arthroscopes & Associated Instruments are available for use in various sizes and configurations, although specific details on sizes and storage are not provided.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821359 Date27 May 1982ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HRX
FDA applicant
Downs Surgical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What are Arthroscopes & Associated Instruments used for?

    Arthroscopes & Associated Instruments are used in surgical procedures to visualize and diagnose conditions within joints, providing a clear view for accurate diagnosis and treatment in orthopedic settings.

  • How are Arthroscopes & Associated Instruments supplied and cleared for use?

    The device is supplied by Downs Surgical, Ltd. and has been cleared by the FDA under the traditional 510(k) process with clearance number K821359, indicating it is substantially equivalent to legally marketed devices.

  • What regulatory classification applies to Arthroscopes & Associated Instruments?

    The device is classified under product code HRX and was reviewed by the Orthopedic advisory committee (OR), reflecting its classification within orthopedic surgical devices based on its intended use and technology.