FDA product code NSI: System, Imaging, Esophageal, Wireless, Capsule
NSI is the FDA product code for system, imaging, esophageal, wireless, capsule. It is a Class II device, regulated under 21 CFR 876.1300 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under NSI. The average 510(k) review took 97 days (median 61).
Definition
THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS INTENDED FOR VISUALIZATION OF THE ESOPHAGUS RATHER THAN THE SMALL BOWEL.
Classification
| Field | Value |
|---|---|
| Device name | System, Imaging, Esophageal, Wireless, Capsule |
| Device class | Class II |
| Regulation | 21 CFR 876.1300 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NSI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 45 |
Compare with all 510(k) review times · Search every NSI clearance
Top NSI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Given Imaging , Ltd. | 7 | 2018-03-08 |
Most recent NSI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180171 | Given Imaging , Ltd. | PillCam Patency System | 2018-03-08 | 45 |
| K090557 | Given Imaging , Ltd. | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM | 2009-09-28 | 210 |
| K071153 | Given Imaging , Ltd. | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | 2007-06-11 | 47 |
| K060805 | Given Imaging , Ltd. | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | 2006-05-24 | 61 |
| K052184 | Given Imaging , Ltd. | GIVEN DIAGNOSTIC SYSTEM | 2005-12-01 | 112 |
Recalls for NSI devices
openFDA lists no recalls for product code NSI.
Frequently asked questions
What is FDA product code NSI?
NSI is the FDA product code for system, imaging, esophageal, wireless, capsule. It is a Class II device, regulated under 21 CFR 876.1300 and reviewed by the Gastroenterology and Urology panel.
What device class is NSI?
Class II, regulation 21 CFR 876.1300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NSI?
Across 7 cleared submissions the average was 97 days from receipt to decision (median 61).
Which companies have the most NSI clearances?
Given Imaging , Ltd. (7).
Next steps
- Run an FDA pathway report with predicate devices for product code NSI
- Run a recall and safety report across every NSI manufacturer
- Watch product code NSI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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