510(k) K090557
K090557 is an FDA 510(k) premarket notification submitted by Given Imaging , Ltd. for the device "GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM". The FDA issued a decision of Substantially Equivalent on September 28, 2009. The device falls under product code NSI (System, Imaging, Esophageal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Given Imaging , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2009
- Date Received
- March 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Esophageal, Wireless, Capsule
- Device Class
- Class II
- Regulation Number
- 876.1300
- Review Panel
- GU
- Submission Type
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.