RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

• K Number: K251826
• Device Name: RENASYS WOUND+ Dressing Kit with AIRLOCK Technology
• Manufacturer: Smith & Nephew Medical Ltd
• Date Cleared: 2025-09-11 ( 90 days)
• Product Code: OMP
• Regulation Number: 878.4780
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.