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Medscope 4MM Arthroscope

by Medscope Corp.

510(k) K894303

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 NumberK894303 Date25 Jul 1989ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Medscope 4mm Arthroscope is a diagnostic and surgical device classified as an arthroscope, designed for visual inspection and minimally invasive procedures within joints. It features a 4mm diameter shaft to facilitate entry into small articular spaces, enabling orthopedic surgeons to examine internal joint structures such as cartilage, ligaments, and bone surfaces. The device is equipped with an optical system to transmit high-resolution images, aiding in the assessment of joint pathology and guiding therapeutic interventions. Its compact design supports precision and reduces tissue trauma during arthroscopic examinations.

This device is supplied as a reusable medical instrument, intended for use in orthopedic surgical settings under sterile conditions. It must be thoroughly cleaned, disinfected, and sterilized between procedures to prevent cross-contamination. The Medscope 4mm Arthroscope adheres to FDA 510(k) clearance (K894303) under the Orthopedic advisory committee, classified under product code HRX. Compliance with regulatory standards ensures its safe application in arthroscopic procedures, with no specific MRI safety restrictions noted in the available data.

Other devices from Medscope Corp.

Questions

AI-generated answers, 1 Oct 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 Medscope 4mm Arthroscope used for?

    The Medscope 4mm Arthroscope is designed for visual inspection and minimally invasive procedures within joints, enabling orthopedic surgeons to examine internal joint structures such as cartilage, ligaments, and bone surfaces to assess joint pathology and guide therapeutic interventions.

  • Is the Medscope 4mm Arthroscope reusable or single-use?

    The Medscope 4mm Arthroscope is supplied as a reusable medical instrument, intended for use in orthopedic surgical settings under sterile conditions, and must be thoroughly cleaned, disinfected, and sterilized between procedures to prevent cross-contamination.

  • What is the shaft diameter of the Medscope 4mm Arthroscope and why is it significant?

    The Medscope 4mm Arthroscope features a 4mm diameter shaft, which facilitates entry into small articular spaces, allowing access to tight joint areas for detailed visualization during diagnostic and surgical arthroscopic procedures.

  • What regulatory pathway was used for the Medscope 4mm Arthroscope?

    The Medscope 4mm Arthroscope received FDA 510(k) clearance (K894303) through a traditional submission process, reviewed by the Orthopedic advisory committee, and is classified under product code HRX as substantially equivalent to a legally marketed device.