NSI · System, Imaging, Esophageal, Wireless, Capsule
Gastroenterology, Urology · 21 CFR 876.1300 · Class 2
Overview
| Product Code | NSI |
|---|---|
| Device Name | System, Imaging, Esophageal, Wireless, Capsule |
| Regulation | 21 CFR 876.1300 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.
Classification Rationale
Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K180171 | PillCam Patency System | Given Imaging , Ltd. | Mar 8, 2018 | SESE |
| K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM | Given Imaging , Ltd. | Sep 28, 2009 | SESE |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | Given Imaging , Ltd. | Jun 11, 2007 | SESE |
| K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | May 24, 2006 | SESE |
| K052184 | GIVEN DIAGNOSTIC SYSTEM | Given Imaging , Ltd. | Dec 1, 2005 | SESE |
| K042960 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO | Given Imaging , Ltd. | Nov 24, 2004 | SESE |
| K041149 | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE | Given Imaging , Ltd. | Oct 25, 2004 | SESE |
Top Applicants
- Given Imaging , Ltd. — 7 clearances
