FDA.reportPublic FDA data

De Novo DEN170024

Device
AQUABEAM System
Contact
michael nketiah
De Novo number
DEN170024
Product code
PZP
Regulation
876.4350
Classification name
fluid jet removal system
Decision
granted (DENG)
Decision date
2017-12-21
Date received
2017-04-17
Classification advisory
General & Plastic Surgery
Review advisory
Gastroenterology/Urology
Type
Direct

Current FDA Classification#

Product code
PZP
Device name
Fluid Jet Removal System
Medical specialty
General, Plastic Surgery
Device class
2
Regulation
876.4350
Implant
N
Life sustain/support
N