# DEN120023: Given Pillcam Colon 2 Capsule Endoscopy System

- Pathway: De Novo (Direct)
- Applicant: Given Imaging, Ltd.
- Decided: Jan 29, 2014 after 426 days
- Product code: PGD (Colon Capsule Imaging System)
- Device class: 2
- Regulation: 21 CFR 876.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K153466: PillCam COLON 2 Capsule Endoscopy System (2016), 5 descendants of its own
- K170210: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (2017), 4 descendants of its own
- K211684: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (2021), 3 descendants of its own
- K230991: PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (2023), 1 descendant of its own
- K242643: CapsoCam Plus (SV-3) Capsule Endoscopy System (2024), 0 descendants of its own

Source page: https://510kreport.com/device/DEN120023
Methodology: https://510kreport.com/methodology