Given Imaging , Ltd.
Medical device manufacturer in Yokne'Am Ilit, Isra.
28510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 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 |
| K102543 | Bravo PH Monitoring System and AccessoriesFFT · Traditional | 12/01/2010SE |
| K101200 | Pillcam Express Video Capsules Delivery DeviceNEZ · Traditional | 09/30/2010SE |
| K090557 | Given Pillcam Platform Will Pillcam SB Capsules, Eso Capsules, Given Agile Patency SystemNSI · Traditional | 09/28/2009SE |
| K091405 | Pillcam Platform with Pillcam SB Capsules with Pillcam SensorbeltNEZ · Special | 07/29/2009SE |
| K071153 | Given Diagnostic System with Pillcam ESO2 CapsuleNSI · Special | 06/11/2007SE |
| K070475 | Modificaton to: Given Diagnostic Imaging SystemNEZ · Special | 05/07/2007SE |
| K062786 | Modification to Given Diagnostic SystemNEZ · Special | 10/18/2006SE |
| K060805 | Modification to Given Diagnostic SystemNSI · Special | 05/24/2006SE |
| K053639 | Given Diagnostic SystemNEZ · Traditional | 05/08/2006SE |
| K052184 | Given Diagnostic SystemNSI · Traditional | 12/01/2005SE |
| K042960 | Given Diagnostic System with Pillcam EsoNSI · Special | 11/24/2004SE |
| K041149 | Given Diagnostic System with M2A Eso CapsuleNSI · Traditional | 10/25/2004SE |
| K040248 | Modification to Given Diagnostic SystemNEZ · Special | 02/17/2004SE |
| K032405 | Given Diagnostic SystemNEZ · Traditional | 10/29/2003SE |
| K031033 | Given Diagnostic SystemNEZ · Traditional | 07/01/2003SE |
| K022980 | Modification to Given Diagnostic SystemNEZ · Traditional | 02/27/2003SE |
| K022362 | Given Diagnostics SystemNEZ · Special | 08/09/2002SE |
| K020341 | Given Diagnostic SystemNEZ · Traditional | 05/02/2002SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-3090-2026 Class I | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule…Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient… | 08/06/2026Open, Classified |
| Z-2047-2025 Class I | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule…It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its… | 06/03/2025Open, Classified |
| Z-0966-2012 | Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS#…Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach… | 01/11/2012Terminated |
| Z-1748-2011 | Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB…The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval. | 03/08/2011Terminated |
| Z-1447-2008 | Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging…The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in… | 12/13/2007Terminated |