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Smith+Nephew Arthroscopes

by Smith & Nephew, Inc.

510(k) K201349

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 NumberK201349 Date20 Jul 2020ClearedStatusActive

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  • Withdrawn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
FDA applicant
Smith & Nephew
Device class
Class II
Regulation
21 CFR Part 888.1100
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Smith+Nephew Arthroscopes are orthopedic devices designed for joint visualization during arthroscopic procedures. They are video arthroscopes available in various diameters and lengths, including configurations such as 4mm diameter with a 30° angle of view.

These arthroscopes are supplied as reusable devices, featuring an autoclavable design for sterilization and reuse. They are intended for use with the LENS HD or LENS 4K Surgical Imaging System to enhance brightness, color transmission, and image quality. Authorization is based on FDA 510(k) clearance under product code HRX, with substantial equivalence established via traditional review.

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Questions

AI-generated answers, 25 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 Smith+Nephew Arthroscope used for?

    The Smith+Nephew Arthroscope is an orthopedic device designed for joint visualization during arthroscopic procedures, enabling surgeons to view internal joint structures using video imaging technology.

  • Is the Smith+Nephew Arthroscope reusable or single-use?

    The Smith+Nephew Arthroscope is supplied as a reusable device, featuring an autoclavable design that allows for sterilization and multiple uses after proper reprocessing.

  • What sizes and configurations are available for the Smith+Nephew Arthroscope?

    The Smith+Nephew Arthroscope is available in various diameters and lengths, including a specific configuration of 4mm diameter with a 30° angle of view, as stated in the device description.

  • What imaging system is the Smith+Nephew Arthroscope intended to work with?

    The Smith+Nephew Arthroscope is intended for use with the LENS HD or LENS 4K Surgical Imaging System to enhance brightness, color transmission, and image quality during arthroscopic procedures.

  • How was the Smith+Nephew Arthroscope authorized for market release?

    The Smith+Nephew Arthroscope received authorization based on FDA 510(k) clearance under product code HRX, with substantial equivalence established through a traditional review process.