Home / 510(k) Clearances / K202157

510(k) K202157

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 by Smith & Nephew Medical Limited — Product Code OMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2020
Date Received
August 3, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Negative Pressure Wound Therapy Powered Suction Pump
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

Other clearances by Smith & 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)
  • K203716 — PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negati (December 14, 2021)
  • 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 OMP

  • K253429 — Genadyne ASTRA NPWT (March 12, 2026)
  • K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foa (November 21, 2025)
  • K251646 — extriCARE® 1000 Negative Pressure Wound Therapy System (October 3, 2025)
  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (September 11, 2025)
  • K243187 — Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (June 27, 2025)
  • K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS G (February 18, 2025)
  • K233614 — Genadyne DUO NPWT (December 23, 2024)
  • K241061 — VERSA Negative Pressure Wound Therapy System (VCMPP-100) (August 21, 2024)
  • K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand) (August 19, 2024)
  • K241515 — NEXA™ NPWT System (July 26, 2024)