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Irrigation Set

by Edwards Orthopaedics Div., Baxter Healthcare Corp.

510(k) K883300

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 NumberK883300 Date1 Nov 1988ClearedStatusActive

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  • Withdrawn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, 28 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 Irrigation Set is a medical device used for irrigation purposes. It is classified under the product code HRX and is described as substantially equivalent. The device is used in orthopedic applications.

The Irrigation Set is supplied sterile and is intended for single-use. It is available in a length of 82 inches (2.1 m) and is used with irrigating solutions in plastic containers. The device has been cleared by the FDA with the k number K883300 and is regulated under 21 CFR 888.1100.

Other devices from Edwards Orthopaedics Div., Baxter Healthcare Corp.

Questions

AI-generated answers, 28 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 Irrigation Set used for?

    The Irrigation Set is used for irrigation purposes in orthopedic applications, facilitating the use of irrigating solutions.

  • Is the Irrigation Set supplied sterile?

    Yes, the Irrigation Set is supplied sterile and is intended for single-use, reducing the risk of infection.

  • What is the length of the Irrigation Set?

    The Irrigation Set is available in a length of 82 inches (2.1 m), providing sufficient reach for various orthopedic procedures.