Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT

K-Number: K103088 · 2011-01-14

ApplicantGiven Imaging , Ltd.
Decision Date2011-01-14
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2011-01-14 under 510(k) number K103088. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT?

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT is a medical device that received FDA 510(k) clearance on 2011-01-14. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K103088.

When did GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT receive FDA 510(k) clearance?

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT received FDA 510(k) clearance on 2011-01-14, under 510(k) number K103088.

Who is the listed applicant for GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT?

The FDA 510(k) record lists Given Imaging , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT?

The FDA product code for GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT is NEZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Given Imaging , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180171PillCam Patency SystemK170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0K170839RAPID WebK151086ManoScan SystemK153466PillCam COLON 2 Capsule Endoscopy SystemK123864GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM

View all 27 devices →

Related Devices (Code: NEZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252617MiroCam® Capsule Endoscope SystemIntromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) Capsule Endoscopy SystemCapsoVision, Inc.K240276PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader SoftwareGiven Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0EGiven Imaging Ltd. (Medtronic)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑