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510(k) K172005

PICO 7 Single Use Negative Pressure Wound Therapy System by Smith & Nephew Medical Limited — Product Code OMP

K172005 is an FDA 510(k) premarket notification submitted by Smith & Nephew Medical Limited for the device "PICO 7 Single Use Negative Pressure Wound Therapy System". The FDA issued a decision of Substantially Equivalent on February 2, 2018. The device falls under product code OMP (Negative Pressure Wound Therapy Powered Suction Pump), a Class II device regulated under 21 CFR 878.4780. Smith & Nephew Medical Limited has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2018
Date Received
July 3, 2017
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)
  • 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)

Other clearances for product code OMP

  • K253263 — ConvaVAC™ Negative Pressure Wound Therapy System (June 24, 2026)
  • K253199 — CURASYS 2 (EMDN0003) (June 23, 2026)
  • K260646 — RENASYS EDGE (66803126) (May 27, 2026)
  • K261291 — Nisus NPWT Canister 500-mL (CPC-500) (May 21, 2026)
  • K254019 — Wound Geni NPWT System (May 4, 2026)
  • 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)

FDA data resources