Prevena Plus 125 Therapy Unit— 510(k) K223263

Clearance details

Applicant

3M

Product code

Code QFC

Device class

Class 2

Regulation

21 CFR 878.4783

Advisory panel

General, Plastic Surgery

Date received

2022-10-24

Decision date

2023-02-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Antionio, TX, US

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• Z-1175-2025 — 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CMClass II·Ongoing·KCI USA, INC.·20250117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K223263.