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510(k) K153199

Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack by Kci USA, Inc. — Product Code OMP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 29, 2016
Date Received
November 2, 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.

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  • 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)
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