Company ยท IL
Given Imaging , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2018. Name variants (Inc, Corp, punctuation) are merged.
30510(k) clearances (0 in 12 months)
5recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2018 | K180171 | PillCam Patency System Given Imaging , Ltd., IL | NSI |
| Sep 1, 2017 | K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 Given Imaging , Ltd., IL | NEZ |
| May 26, 2017 | K170839 | RAPID Web Given Imaging , Ltd., IL | NEZ |
| Apr 28, 2016 | K151086 | ManoScan System Given Imaging , Ltd., IL | FFX |
| Jan 14, 2016 | K153466 | PillCam COLON 2 Capsule Endoscopy System Given Imaging , Ltd., IL | PGD |
| Dec 17, 2014 | K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd., IL | NEZ |
| Jan 29, 2014 | DEN120023 | GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd., IL | PGD |
| Aug 12, 2013 | K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM Given Imaging , Ltd., IL | NEZ |
| May 13, 2011 | K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES Given Imaging , Ltd., IL | NEZ |
| Mar 7, 2011 | K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES Given Imaging , Ltd., IL | NEZ |
| Jan 14, 2011 | K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT Given Imaging , Ltd., IL | NEZ |
| Dec 1, 2010 | K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES Given Imaging , Ltd., IL | FFT |
| Sep 30, 2010 | K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE Given Imaging , Ltd., IL | NEZ |
| Sep 28, 2009 | K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM Given Imaging , Ltd., IL | NSI |
| Jul 29, 2009 | K091405 | PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT Given Imaging , Ltd., IL | NEZ |
| Jun 11, 2007 | K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE Given Imaging , Ltd., CA | NSI |
| May 7, 2007 | K070475 | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM Given Imaging , Ltd., CA | NEZ |
| Oct 18, 2006 | K062786 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| May 24, 2006 | K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NSI |
| May 8, 2006 | K053639 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Dec 1, 2005 | K052184 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NSI |
| Nov 24, 2004 | K042960 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO Given Imaging , Ltd., IL | NSI |
| Oct 25, 2004 | K041149 | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE Given Imaging , Ltd., IL | NSI |
| Feb 17, 2004 | K040248 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Oct 29, 2003 | K032405 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Jul 1, 2003 | K031033 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Feb 27, 2003 | K022980 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Aug 9, 2002 | K022362 | GIVEN DIAGNOSTICS SYSTEM Given Imaging , Ltd., IL | NEZ |
| May 2, 2002 | K020341 | GIVEN DIAGNOSTIC SYSTEM Given Imaging , Ltd., IL | NEZ |
| Aug 1, 2001 | DEN010002 | GIVEN DIAGNOSTIC IMAGING SYSTEM Given Imaging , Ltd., IL | NEZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Given Imaging Ltd. Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635,
Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus. Open, Classified |
FFT | None listed |
| Jul 10, 2025 | Given Imaging Ltd. Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack) Open, Classified |
FFT | K102543 |
| Feb 6, 2012 | Given Imaging Ltd. Bravo pH Monitoring capsule, UPC 7290101361695 (FGS# 0312) and UPC 7290101361688 (FGS# 0313).
Product Usage:
The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement Terminated |
LLT | K102543 |
| Mar 23, 2011 | Given Imaging Ltd. Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak). Terminated |
NEZ | K101200 |
| Aug 20, 2008 | Given Imaging Inc Given Diagnostic System with PillCam SB Capsule - Gastrointestinal capsule imaging system. The device is an ingestible telemetric gastrointestinal capsule imaging system is used for visualization of Terminated |
NEZ | None listed |