Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System
FDA 510(k) K090557 · Given Imaging , Ltd.
510(k) numberK090557
Submission
- Device name
- Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System
- Applicant
- Given Imaging , Ltd.
Yoqneaam, IL - Received
- March 2, 2009
- Decision date
- September 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NSI – System, Imaging, Esophageal, Wireless, Capsule
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1300
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code NSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180171 | PillCam Patency SystemNSI · Traditional | Given Imaging , Ltd. | 03/08/2018SE |
| K071153 | Given Diagnostic System with Pillcam ESO2 CapsuleNSI · Special | Given Imaging , Ltd. | 06/11/2007SE |
| K060805 | Modification to Given Diagnostic SystemNSI · Special | Given Imaging , Ltd. | 05/24/2006SE |
| K052184 | Given Diagnostic SystemNSI · Traditional | Given Imaging , Ltd. | 12/01/2005SE |
| K042960 | Given Diagnostic System with Pillcam EsoNSI · Special | Given Imaging , Ltd. | 11/24/2004SE |
| K041149 | Given Diagnostic System with M2A Eso CapsuleNSI · Traditional | Given Imaging , Ltd. | 10/25/2004SE |
More from Given Imaging , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K180171 | PillCam Patency SystemNSI · Traditional | 03/08/2018SE |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0NEZ · Traditional | 09/01/2017SE |
| K170839 | RAPID WebNEZ · Traditional | 05/26/2017SE |
| K151086 | ManoScan SystemFFX · Traditional | 04/28/2016SE |
| K153466 | PillCam COLON 2 Capsule Endoscopy SystemPGD · Traditional | 01/14/2016SE |
| K140284 | Given Pillcam Ugi Capsule Endoscopy SystemNEZ · Traditional | 12/17/2014SE |
| K123864 | Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy SystemNEZ · Traditional | 08/12/2013SE |
| K103025 | Given Pillcam Platform with Rapid 6.5 / Given Pillcam Platform with Pillcam Eso 3 CapsulesNEZ · Traditional | 05/13/2011SE |
| K101250 | Given Pillcam Platform with Pillcam SB CapsulesNEZ · Traditional | 03/07/2011SE |
| K103088 | Given Pillcam Platform with Pillcam SB Capsuleswith Pillcam R SensorbeltNEZ · Traditional | 01/14/2011SE |
Questions and answers
When was Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System cleared by the FDA?
Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency System (K090557) received a 510(k) decision of Substantially Equivalent on September 28, 2009, 210 days after the submission was received.
What is the product code of K090557?
The FDA product code is NSI – System, Imaging, Esophageal, Wireless, Capsule, a Class II (moderate risk) device regulated under 21 CFR 876.1300.