RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit With Soft Port Device

Negative Pressure Wound Therapy Powered Suction Pump

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Renasys¿ Ez Max Negative Pressure Wound Therapy Device, Renasys¿ Ab Abdominal Dressing Kit With Soft Port Device.

Pre-market Notification Details

• Device ID: K143133
• 510k Number: K143133
• Device Name: RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit With Soft Port Device
• Classification: Negative Pressure Wound Therapy Powered Suction Pump
• Applicant: SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St. Petersburg, FL 33716
• Contact: Laura Reynolds
• Correspondent: Laura Reynolds; SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St. Petersburg, FL 33716
• Product Code: OMP
• CFR Regulation Number: 878.4780 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-10-31
• Decision Date: 2015-07-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30040565127256	K143133	000