# Given Imaging, Ltd.

- Location (FDA's records): Yoqneam, IL
- FDA decisions: 30 (2001–2018): 28 510(k) clearances and 2 De Novo grants
- Product codes: NEZ (19), NSI (7), PGD (2), FFX (1), FFT (1)
- 510(k) review time since 2016: median 220 days, against 83 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 106 (102 its own); citations of its devices by later devices: 115 (102 its own)
- Recalls linked to its devices: 5 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sierra Scientific Instruments, Inc.: 1 (https://510kreport.com/company/sierra-scientific-instruments)
- Medtronic Functional Diagnostics A/S: 1 (https://510kreport.com/company/medtronic-functional-diagnostics-a-s)
- Endonetics, Inc.: 1 (https://510kreport.com/company/endonetics)
- United States Endoscopy Group, Inc.: 1 (https://510kreport.com/company/united-states-endoscopy-group)

## Firms that cite its devices most
- Olympus Medical Systems Corp.: 6 (https://510kreport.com/company/olympus-medical-systems)
- Intromedic Co., Ltd.: 3 (https://510kreport.com/company/intromedic)
- Given Imaging Ltd. (Medtronic): 2 (https://510kreport.com/company/given-imaging-medtronic)
- CapsoVision, Inc.: 1 (https://510kreport.com/company/capsovision)
- Ankon Technologies Co., Ltd.: 1 (https://510kreport.com/company/ankon-technologies)

## Its most-cited devices
- DEN010002: Given Diagnostic Imaging System (2001), cited by 13
- K020341: Given Diagnostic System (2002), cited by 12
- K022362: Given Diagnostics System (2002), cited by 11
- K022980: Modification to Given Diagnostic System (2003), cited by 10
- K031033: Given Diagnostic System (2003), cited by 9
- K032405: Given Diagnostic System (2003), cited by 7

## Recent decisions
- K180171: PillCam Patency System (Mar 8, 2018)
- K170210: PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0 (Sep 1, 2017)
- K170839: RAPID Web (May 26, 2017)
- K151086: ManoScan System (Apr 28, 2016)
- K153466: PillCam COLON 2 Capsule Endoscopy System (Jan 14, 2016)
- K140284: Given Pillcam Ugi Capsule Endoscopy System (Dec 17, 2014)
- DEN120023: Given Pillcam Colon 2 Capsule Endoscopy System (Jan 29, 2014)
- K123864: Given Pillcam Endoscopy System with Rapid 8.0, Given Pillcam SB 3 Capsule Endoscopy System (Aug 12, 2013)

Source page: https://510kreport.com/company/given-imaging