De Novo DEN170015

Device

Hemospray Endoscopic Hemostat

Contact

marge walls-walker

De Novo number

DEN170015

Product code

QAU

Regulation

878.4456

Classification name

hemostatic device for endoscopic gastrointestinal use

Decision

granted (DENG)

Decision date

2018-05-07

Date received

2017-03-09

Classification advisory

General & Plastic Surgery

Review advisory

General & Plastic Surgery

Type

Direct