FDA 510(k) Applications Submitted by SMITH & NEPHEW MEDICAL LIMITED

FDA 510(k) Number Submission Date Device Name Applicant
K223526 11/23/2022 ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Com Smith & Nephew Medical Limited
K180614 03/08/2018 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K180618 03/09/2018 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K180698 03/16/2018 PICO 7 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K181822 07/09/2018 RENASYS Touch; RENASYS Y-Connector Smith & Nephew Medical Limited
K181204 05/07/2018 RENASYS Y-Connector; RENASYS TOUCH Smith & Nephew Medical Limited
K191760 07/01/2019 PICO 14 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K161289 05/09/2016 DURAFIBER Ag SMITH & NEPHEW MEDICAL LIMITED
K172005 07/03/2017 PICO 7 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K172519 08/21/2017 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K172521 08/21/2017 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K163387 12/02/2016 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K153723 12/28/2015 ACTICOAT Surgical Dressing Smith & Nephew Medical Limited
K182323 08/27/2018 PICO 7Y Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited
K202157 08/03/2020 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, PICO Fluid Management Pack Smith & Nephew Medical Limited
K202783 09/22/2020 Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing Smith & Nephew Medical Limited
K220964 04/01/2022 VERSAJET Hydrosurgery System (III) Smith & Nephew Medical Limited
K223041 09/29/2022 Renasys Edge (66803126) Smith & Nephew Medical Limited


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