PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System— 510(k) K203716

Substantially Equivalent

Smith and Nephew Medical Limited

FDA 510(k) clearance K203716 for PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, Substantially Equivalent on 2021-12-14. Applicant: Smith and Nephew Medical Limited. Device class: 2.

Clearance details

Applicant
Smith and Nephew Medical Limited
Product code
Code QFC
Device class
Class 2
Regulation
21 CFR 878.4783
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hull, GB
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