Skip to contentDe Novo DEN120023
- Device
- GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
- Contact
- tim thomas
- De Novo number
- DEN120023
- Product code
- PGD
- Regulation
- 876.1330
- Classification name
- colon capsule imaging system
- Decision
- granted (DENG)
- Decision date
- 2014-01-29
- Date received
- 2012-11-29
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- PGD
- Device name
- Colon Capsule Imaging System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.1330
- Implant
- N
- Life sustain/support
- N