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Tuta Healthcare Arthroscopy Flushing Set, Model 80.601

by Tuta Healthcare Pty Limited

510(k) K020083

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 NumberK020083 Date12 Feb 2002ClearedStatusActive

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  • Withdrawn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, 24 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 Tuta Healthcare Arthroscopy Flushing Set, Model 80.601 is a gravity system for fluid management during arthroscopic procedures. It is used to distend the surgical site to enable good visibility and to flush the site continuously to clear debris such as loose bodies or cartilage fragments.

The device is supplied as a system for use in arthroscopic procedures and is authorized under FDA 510(k) clearance K020083. It is classified as a Class II device with product code HRX and was determined to be substantially equivalent to a predicate device on February 12, 2002.

Other devices from Tuta Healthcare Pty Limited

Questions

AI-generated answers, 24 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 Tuta Healthcare Arthroscopy Flushing Set Model 80.601 used for?

    It is used during arthroscopic procedures to distend the surgical site with fluid for better visibility and to continuously flush the joint to remove debris such as loose bodies or cartilage fragments, enabling clearer surgical access and cleaning.

  • How is the Tuta Healthcare Arthroscopy Flushing Set Model 80.601 supplied and operated?

    It is supplied as a complete gravity-fed system designed for use in arthroscopic procedures, relying on gravitational pressure rather than pumps to deliver and circulate irrigation fluid for site distension and debris clearance.

  • Is the Tuta Healthcare Arthroscopy Flushing Set Model 80.601 reusable or single-use?

    The device data does not specify whether the set is reusable or single-use; therefore, no determination can be made about its reusability based solely on the provided information, which focuses on its FDA 510(k) authorization and intended use.