GIVEN IMAGING LTD.

FDA Device Registration & Listing · Yoqneam Northern, IL · Registration 9710107

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9710107
FEI Number
3003348376
Entity Name
GIVEN IMAGING LTD.
City/State/Country
Yoqneam Northern, IL
Establishment Address
2 Hacarmel St., NEW INDUSTRIAL Park, POB 258, Yoqneam Northern 2069204, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GIVEN IMAGING INC. (Owner Number: 10091555)
Owner / Operator Contact Address
15 HAMPSHIRE STREET, Mansfield, MA 02048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230991
PMA Number
N/A

All Registered Proprietary Names

RAPID 8 PillCam UGI Capsule Accessories DR3 SB 3 Patency Capsule Reflux and AccuView software Bravo System Bravo™ Reflux Capsule with Delivery Device Bravo™ CF reflux recorder Versaflex pH Z catheters pHersaflex pH catheters Digitrapper pH Z Versaflex pH catheters Reflux software AccuView pH & pH-Z software SB 3 capsule imaging system- PillCam SB 3 capsule; PillCam endoscopy system; PillCam Software SmartPill GI Monitoring System, version 2 SmartPill pH.p Capsule SmartPill Capsule Calibration Fluid SmartPill Data Receiver SmartPill Docking Station Activation Fixture SmartPill MotiliGI Software PillCam software PillCam Crohn capsule PillCam endoscopy system Disposable Balloons Manoscan catheters ManoScan sw ManoView AR sw ManoScan Impedance module (Z) A200 ManoShield (disposable sanitary sheaths) ManoView ESO sw ManoScan 3D HRM A300 module ManoScan base pressure module ( A120) ManoScan System RAPID Software PillCam COLON 2 Capsule Endoscopy System PillCam™ Cloud Reader Software

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15
NSI System, Imaging, Esophageal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15
PGD Colon Capsule Imaging System Gastroenterology, Urology Class 2 876.1330 2024-10-15
NSI System, Imaging, Esophageal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15
FFT Electrode, Ph, Stomach Gastroenterology, Urology Class 1 876.1400 2024-10-15
FFT Electrode, Ph, Stomach Gastroenterology, Urology Class 1 876.1400 2024-10-15
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15
NYV Gastrointestinal Motility System, Capsule Gastroenterology, Urology Class 2 876.1725 2024-10-15
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15
PGD Colon Capsule Imaging System Gastroenterology, Urology Class 2 876.1330 2024-10-15
FFX System, Gastrointestinal Motility (Electrical) Gastroenterology, Urology Class 2 876.1725 2024-10-15
PGD Colon Capsule Imaging System Gastroenterology, Urology Class 2 876.1330 2024-10-15
NEZ System, Imaging, Gastrointestinal, Wireless, Capsule Gastroenterology, Urology Class 2 876.1300 2024-10-15

Official Correspondent

AVISHAG METZER

US Agent Details

Marsha Seetaram Business: Medtronic, Inc. Email: marsha.n.seetaram@medtronic.com Phone: (904) 2812763

Related Public Records

Same Entity

GIVEN IMAGING INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007662958 Given Imaging Vietnam Co., Ltd. Ho Chi Minh City, VN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K883960 Vascular Technology Incorporated GIPHY MONITOR 1989-10-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710107. Last updated year: 2026. Please use registration number 9710107 when referencing this establishment in official correspondence.
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