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Artscan Cartilage Stiffness Testing Device

by Artscan Medical Innovations

510(k) K010303

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010303 Date11 Sep 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NGR
Device Class
Class II
Regulation
21 CFR Part 888.1100
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The Artscan Cartilage Stiffness Testing Device is an arthroscopic tester used for measuring cartilage stiffness in orthopedic procedures. It is designed to provide quantitative assessment of cartilage properties during surgical interventions.

This device is supplied as a Class II medical device with FDA 510K clearance (K010303). It is intended for single-use in orthopedic settings and requires appropriate storage conditions. The device is not MRI compatible and should be handled according to standard medical device protocols.

Questions

AI-generated answers, 23 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 Artscan Cartilage Stiffness Testing Device used for?

    The Artscan Cartilage Stiffness Testing Device is an arthroscopic tester designed for measuring cartilage stiffness during orthopedic procedures. It provides quantitative assessment of cartilage properties during surgical interventions to help clinicians evaluate tissue condition.

  • How is the Artscan Cartilage Stiffness Testing Device supplied?

    The device is supplied as a Class II medical device with FDA 510K clearance (K010303). It is intended for single-use in orthopedic settings and requires appropriate storage conditions according to standard medical device protocols.

  • Is the Artscan Cartilage Stiffness Testing Device reusable or MRI compatible?

    The Artscan Cartilage Stiffness Testing Device is designed for single-use only and is not MRI compatible. It should be handled according to standard medical device protocols and disposed of after a single procedure to ensure safety and accurate results.

  • What regulatory approvals does the Artscan Cartilage Stiffness Testing Device have?

    The device has FDA 510K clearance (K010303) with a decision code of SESE (Substantially Equivalent) and was reviewed by the Orthopedic advisory committee. It is classified as a Class II medical device under product code NGR.