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510(k) K231939

Renasys Edge by Smith & Nephew Medical, Ltd. — Product Code OMP

K231939 is an FDA 510(k) premarket notification submitted by Smith & Nephew Medical, Ltd. for the device "Renasys Edge". The FDA issued a decision of Substantially Equivalent on May 24, 2024. 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, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2024
Date Received
June 30, 2023
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.

  • K260646 — RENASYS EDGE (66803126) (May 27, 2026)
  • 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)
  • K190730 — IODOSORB (December 20, 2019)
  • K190756 — IODOFLEX (December 20, 2019)
  • K153209 — RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS (August 4, 2016)
  • 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

  • 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