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510(k) K153209

RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply by Smith & Nephew Medical, Ltd. — Product Code OMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2016
Date Received
November 5, 2015
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, Ltd.

  • K251826 — RENASYS WOUND+ Dressing Kit with AIRLOCK Technology (September 11, 2025)
  • K243576 — RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS G (February 18, 2025)
  • K231939 — Renasys Edge (May 24, 2024)
  • K190756 — IODOFLEX (December 20, 2019)
  • K190730 — IODOSORB (December 20, 2019)
  • K151436 — PICO Single Use Negative Pressure Wound Therapy System (January 28, 2016)
  • K891444 — PERRY* STERILE X-AM* GLOVES (September 19, 1989)
  • K892353 — PERRY* NON-STERILE X-AM* GLOVES (May 25, 1989)
  • K891712 — PERRY* LATEX FLOOR GLOVES (April 27, 1989)

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)