510(k) K111280

V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT by Kci USA, Inc. — Product Code OMP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 21, 2011
Date Received: May 6, 2011
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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Other clearances for product code OMP

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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)