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

FDA 510(k)

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

K-Number: K211684 · 2021-08-27

ApplicantGiven Imaging Ltd. (Medtronic)
Decision Date2021-08-27
Product CodeNEZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is a medical device manufactured by Given Imaging Ltd. (Medtronic). It received FDA 510(k) clearance on 2021-08-27 under approval number K211684. 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 PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is a medical device that received FDA 510(k) clearance on 2021-08-27. It is manufactured by Given Imaging Ltd. (Medtronic). The 510(k) number is K211684.

When was PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E approved by the FDA?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E received FDA 510(k) clearance on 2021-08-27, under approval number K211684.

What company makes PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is manufactured by Given Imaging Ltd. (Medtronic).

What is the FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E?

The FDA product code for PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E is NEZ.

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT04605302 Comparative Study of MCCE With/Without Tether vs Conventional Upper Endoscopy in Patients With Upper Abdominal Symptoms COMPLETED NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING

Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 40845310 Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification? JMIR mHealth and uHealth (2025)

Other Devices by Given Imaging Ltd. (Medtronic)

K230991PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E

Related Devices (Code: NEZ)

K161773CapsoCam Plus (SV-3) Capsule Endoscope SystemCapsoVision, Inc. K151635CapsoCam (SV-1)CapsoVision, Inc. K170210PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0Given Imaging , Ltd. K170839RAPID WebGiven Imaging , Ltd. K163495AdvanCE capsule endoscope delivery deviceUnited States Endoscopy Group, Inc. K163069OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEMOlympus Medical Systems Corp.

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.

↑