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Douglas Medical Products Irrigation Set

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922318

by Douglas Medical Products Corp.

Identifiers

510(k) Number
K922318 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Douglas Medical Products Irrigation Set is a medical device designed for irrigation procedures. It facilitates the delivery of fluids to a surgical or wound site as required for clinical applications.

This device is supplied by Douglas Medical Products Corp. and has received FDA 510(k) clearance. It is identified under product code HRX and is categorized for use within orthopedic settings.

Frequently asked questions

What is the primary clinical use for the Douglas Medical Products Irrigation Set?

This device is designed to facilitate the delivery of fluids to a surgical or wound site. It is specifically categorized for use within orthopedic clinical settings.

What is the regulatory status of this irrigation set?

The Douglas Medical Products Irrigation Set has received FDA 510(k) clearance under K-number K922318. It was determined to be substantially equivalent to existing devices.

How is this device categorized for regulatory purposes?

The device is identified under product code HRX and falls under the oversight of the Orthopedic advisory committee, which reviews medical equipment intended for use in bone and joint procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Douglas Medical Products, Inc. Irrigation Set, PDF K922318 - Douglas Medical Products, Inc. Irrigation Set, Douglas Medical Products | US Medical Device company registered with ..., DOUGLAS MEDICAL PRODUCTS, INC FDA Filings - FDA.report, Douglas-Medical-Products-Corp FDA Filings - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Douglas Medical Products Corp.

Sources (1)

  • FDA 510(k) K922318 24 fields · synced Sep 22, 2026