← Back to catalogue

Prevena Plus 125 Therapy Unit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223263

by 3m

Identifiers

510(k) Number
K223263 FDA 510(k)
FDA Product Code
QFC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4783 FDA 510(k)
Regulation Number
878.4783 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Prevena Plus 125 Therapy Unit by 3m — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
3m

Sources (1)

  • FDA 510(k) K223263 24 fields · synced Jun 18, 2026