Prevena Plus 125 Therapy Unit
K-Number: K223263 · 2023-02-13
Applicant3M
Decision Date2023-02-13
Product CodeQFC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Prevena Plus 125 Therapy Unit is a medical device manufactured by 3M. It received FDA 510(k) clearance on 2023-02-13 under approval number K223263. The device is classified under product code QFC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Prevena Plus 125 Therapy Unit?
Prevena Plus 125 Therapy Unit is a medical device that received FDA 510(k) clearance on 2023-02-13. It is manufactured by 3M. The 510(k) number is K223263.
When was Prevena Plus 125 Therapy Unit approved by the FDA?
Prevena Plus 125 Therapy Unit received FDA 510(k) clearance on 2023-02-13, under approval number K223263.
What company makes Prevena Plus 125 Therapy Unit?
Prevena Plus 125 Therapy Unit is manufactured by 3M.
What is the FDA product code for Prevena Plus 125 Therapy Unit?
The FDA product code for Prevena Plus 125 Therapy Unit is QFC.
Other Devices by 3M
Related Devices (Code: QFC)
DEN180013PREVENA 125 and PREVENA PLUS 125 Therapy UnitsKci USA, Inc.
K203716PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith and Nephew Medical Limited
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.