Product code NSI— Gastroenterology, Urology
GIVEN DIAGNOSTIC SYSTEM
- Classification name
- System, Imaging, Esophageal, Wireless, Capsule
- Device class
- Class 2
- Regulation
- 21 CFR 876.1300
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 7
- First cleared
- Most recent
FDA classification 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.”
Market context for product code NSI
FDA has cleared devices under product code NSI between 2004 and 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2018
- 2009
- 2007
- 2006
- 2005
- 2004
Top applicants under product code NSI
Recent clearances under product code NSI
- K180171 — PillCam Patency System
- K090557 — GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM
- K071153 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
- K060805 — MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
- K052184 — GIVEN DIAGNOSTIC SYSTEM
- K042960 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
- K041149 — GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE
Data sourced from openFDA. This site is unofficial and independent of the FDA.