# K101200: Pillcam Express Video Capsules Delivery Device

- Pathway: 510(k) (Traditional)
- Applicant: Given Imaging, Ltd.
- Decided: Sep 30, 2010 after 154 days
- Product code: NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule)
- Device class: 2
- Regulation: 21 CFR 876.1300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040494 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040494: Capsule Delivery Device, 160CM, Model 711143; Capsule Delivery Device, 210CM, Model 711144, United States Endoscopy Group, Inc. (2004) Summary page 1.

## Recalls of this device
- Mar 8, 2011 · Not classified · Z-1748-2011: The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.

## Indications for use
The disposable PillCam® Express™ video capsule delivery device is indicated for the transendoscopic delivery of the PillCam® SB video capsule in patients age 8 and above who are either unable to ingest the PillCam capsule or are known to have slow gastric emptying time

Source page: https://510kreport.com/device/K101200
Methodology: https://510kreport.com/methodology