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Arthrotap

by Accuro Technologies, Inc.

510(k) K201816

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 NumberK201816 Date16 Oct 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  • Withdrawn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
FMF
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

Arthrotap is a medical device designed to facilitate intra-articular injections. It functions by providing both aspiration and injection capabilities within a single device.

This device is cleared for use under FDA 510(k) number K201816. It is categorized as a General Hospital device under product code FMF.

Questions

AI-generated answers, 26 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 primary function of the Arthrotap device?

    The Arthrotap is designed to facilitate intra-articular injections. It is engineered to provide both aspiration and injection capabilities within a single device, streamlining the procedure for the clinician.

  • What is the regulatory status of the Arthrotap?

    The Arthrotap is cleared for use under FDA 510(k) number K201816. It is categorized as a General Hospital device under product code FMF, following a traditional clearance process.

  • Who is the manufacturer of the Arthrotap?

    The Arthrotap is manufactured by Accuro Technologies, Inc., located in Victoria, Canada. The device was submitted for regulatory clearance under this applicant name.