PICO

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 Pico.

Pre-market Notification Details

• Device ID: K111170
• 510k Number: K111170
• Device Name: PICO
• Classification: Negative Pressure Wound Therapy Powered Suction Pump
• Applicant: SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. SUITE 110 St. Petersburg, FL 33716
• Contact: Terry Mcmahon
• Correspondent: Terry Mcmahon; SMITH & NEPHEW, INC. 970 LAKE CARILLON DR. 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: 2011-04-26
• Decision Date: 2011-12-15
• Summary: summary