# K153466: PillCam COLON 2 Capsule Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Jan 14, 2016 after 44 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
Longest line of descent: 1 generation back to DEN120023 (2014). 1 ancestor in all.
5 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120023: Given Pillcam Colon 2 Capsule Endoscopy System, Given Imaging, Ltd. (2014) Summary page 4.

## Most influential descendants
- 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
- K240276: PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software (2024), 0 descendants of its own

## Indications for use
The PillCam COLON 2 capsule endoscopy system is intended to provide visualization of the colon. It may be used for detection of colon polyps in patients after an incomplete optical colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. In addition, it is intended for detection of colon polyps in patients with evidence of gastrointestinal bleeding of lower Gl origin. This applies only to patients with major risks for colonoscopy or moderate sedation, but who could tolerate colonoscopy and moderate sedation in the event a clinically significant colon abnormality was identified on capsule endoscopy.

Source page: https://510kreport.com/device/K153466
Methodology: https://510kreport.com/methodology