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510(k) K203716

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 by Smith and Nephew Medical Limited — Product Code QFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2021
Date Received
December 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Device Class
Class II
Regulation Number
878.4783
Review Panel
SU
Submission Type

A negative pressure wound therapy device for reduction of wound complications is a powered suction pump intended for wound management and reduction of wound complications via application of negative pressure to the wound, which removes fluids, including wound exudate, irrigation fluids, and infectious materials. This device type is intended for use with wound dressings classified under 21 CFR 878.4780. This classification does not include devices intended for organ space wounds.

Other clearances by Smith and Nephew Medical Limited

  • K242146 — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (December 17, 2024)
  • K223526 — ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular F (August 18, 2023)
  • K220964 — VERSAJET Hydrosurgery System (III) (May 16, 2023)
  • K213853 — RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing (February 10, 2023)
  • K223041 — Renasys Edge (66803126) (November 22, 2022)
  • K202783 — Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dress (January 14, 2022)
  • K202157 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Neg (October 30, 2020)
  • K191760 — PICO 14 Single Use Negative Pressure Wound Therapy System (December 5, 2019)
  • K181822 — RENASYS Touch; RENASYS Y-Connector (March 21, 2019)
  • K182323 — PICO 7Y Single Use Negative Pressure Wound Therapy System (January 18, 2019)

Other clearances for product code QFC

  • K223263 — Prevena Plus 125 Therapy Unit (February 13, 2023)
  • DEN180013 — PREVENA 125 and PREVENA PLUS 125 Therapy Units (April 19, 2019)