The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.
Devices that are classified into class I or class II through a De Novo classification request may be marketed and used as predicates for future premarket notification [510(k)] submissions.
Manufacturer | Device Name | Date |
---|---|---|
Tangible Boost | 2020-09-24 | |
HemosIL Liquid Anti-Xa | 2020-09-17 | |
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | 2020-08-28 | |
Cell-Free DNA BCT | 2020-08-07 | |
EndeavorRx | 2020-06-15 | |
NaviCam Capsule Endoscope System With NaviCam Stomach Capsule | 2020-05-22 | |
NP Screen | 2020-05-11 | |
ITEAR Neurostimulator | 2020-05-01 | |
OGmend Implant System | 2020-05-01 | |
MyCare Psychiatry Clozapine Assay Kit | 2020-04-16 | |
I-TIND System | 2020-02-25 | |
AmplideX Fragile X Dx & Carrier Screen Kit | 2020-02-21 | |
Surfacer Inside-Out Access Catheter System | 2020-02-10 | |
Caption Guidance | 2020-02-07 | |
Mucosal Integrity Conductivity (MI) Test System | 2019-12-23 | |
Control-IQ Technology | 2019-12-13 | |
GSP Neonatal Creatine Kinase - MM Kit | 2019-12-12 | |
Cobas VivoDx MRSA | 2019-12-05 | |
WOUNDCHEK Bacterial Status | 2019-12-02 | |
EchoTip Insight Portosystemic Pressure Gradient Measuring System | 2019-11-20 |