FDA.reportPublic FDA data

De Novo DEN240013

Device
MagDI System
Contact
lisa griffin vincent
De Novo number
DEN240013
Product code
SAH
Regulation
878.4816
Classification name
magnetic compression anastomosis system
Decision
granted (DENG)
Decision date
2024-07-02
Date received
2024-03-26
Classification advisory
General & Plastic Surgery
Review advisory
General & Plastic Surgery
Type
Post-NSE

Current FDA Classification#

Product code
SAH
Device name
Magnetic Compression Anastomosis System
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
878.4816
Implant
N
Life sustain/support
N