Given Imaging Ltd.
Yoqneam Northern, IL
GIVEN IMAGING LTD. appears in FDA device records in Yoqneam Northern, IL. FDA records list 30 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for Given Imaging Ltd. between 2001 and 2018. The busiest year on record is 2003, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 3 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180171 | PillCam Patency System | NSI | Substantially Equivalent | |
| K170210 | PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 | NEZ | Substantially Equivalent | |
| K170839 | RAPID Web | NEZ | Substantially Equivalent | |
| K151086 | ManoScan System | FFX | Substantially Equivalent | |
| K153466 | PillCam COLON 2 Capsule Endoscopy System | PGD | Substantially Equivalent | |
| K140284 | GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM | NEZ | Substantially Equivalent | |
| DEN120023 | GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM | PGD | Unknown | |
| K123864 | GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM | NEZ | Substantially Equivalent | |
| K103025 | GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES | NEZ | Substantially Equivalent | |
| K101250 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES | NEZ | Substantially Equivalent | |
| K103088 | GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT | NEZ | Substantially Equivalent | |
| K102543 | BRAVO PH MONITORING SYSTEM AND ACCESSORIES | FFT | Substantially Equivalent | |
| K101200 | PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE | NEZ | Substantially Equivalent | |
| K090557 | GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM | NSI | Substantially Equivalent | |
| K091405 | PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT | NEZ | Substantially Equivalent | |
| K071153 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE | NSI | Substantially Equivalent | |
| K070475 | MODIFICATON TO: GIVEN DIAGNOSTIC IMAGING SYSTEM | NEZ | Substantially Equivalent | |
| K062786 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | NEZ | Substantially Equivalent | |
| K060805 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | NSI | Substantially Equivalent | |
| K053639 | GIVEN DIAGNOSTIC SYSTEM | NEZ | Substantially Equivalent | |
| K052184 | GIVEN DIAGNOSTIC SYSTEM | NSI | Substantially Equivalent | |
| K042960 | GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO | NSI | Substantially Equivalent | |
| K041149 | GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE | NSI | Substantially Equivalent | |
| K040248 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | NEZ | Substantially Equivalent | |
| K032405 | GIVEN DIAGNOSTIC SYSTEM | NEZ | Substantially Equivalent | |
| K031033 | GIVEN DIAGNOSTIC SYSTEM | NEZ | Substantially Equivalent | |
| K022980 | MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM | NEZ | Substantially Equivalent | |
| K022362 | GIVEN DIAGNOSTICS SYSTEM | NEZ | Substantially Equivalent | |
| K020341 | GIVEN DIAGNOSTIC SYSTEM | NEZ | Substantially Equivalent | |
| DEN010002 | GIVEN DIAGNOSTIC IMAGING SYSTEM | NEZ | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9710107 | 3003348376 | GIVEN IMAGING LTD. | 2 Hacarmel St., Yoqneam Northern 2069204 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2047-2025 | 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) | It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. | Class I | Open, Classified | |
| Z-0966-2012 | 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 and monitoring of gastric reflux in adults and children form 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. | Failure of the Bravo capsule to attach to the esophagus or alternatively, failure of the capsule to detach from the placement device. | Terminated | ||
| Z-1748-2011 | 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). | The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval. | Terminated | ||
| Z-1447-2008 | 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 the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories. | The cards included in the product's education kit (proposing a clinical algorithm for capsule endoscopy in patients with suspected Crohn's disease), were printed incorrectly. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain