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FDA 510(k)

Capsule Surveillance System

K-Number: K213335 · 2022-01-14

ApplicantCapsule Surveillance Technologies, Sas /Capsule Tech, Inc.
Decision Date2022-01-14
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Capsule Surveillance System is a medical device manufactured by Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. It received FDA 510(k) clearance on 2022-01-14 under approval number K213335. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Capsule Surveillance System?

Capsule Surveillance System is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. The 510(k) number is K213335.

When was Capsule Surveillance System approved by the FDA?

Capsule Surveillance System received FDA 510(k) clearance on 2022-01-14, under approval number K213335.

What company makes Capsule Surveillance System?

Capsule Surveillance System is manufactured by Capsule Surveillance Technologies, Sas /Capsule Tech, Inc..

What is the FDA product code for Capsule Surveillance System?

The FDA product code for Capsule Surveillance System is MWI.

Related Clinical Trials

NCT03636230 Virtual E-health System for Pacemakers ACTIVE_NOT_RECRUITING NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery ENROLLING_BY_INVITATION NCT06315023 The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) ENROLLING_BY_INVITATION NCT07089615 Prospective, Open-label, Non-significant Risk, Multicenter Study Comparing the Polyp Detection of the Study Device to That of the Colonoscopy Reference RECRUITING NCT04484220 Ellipsys Vascular Access System Post Market Surveillance (PS) Study COMPLETED NCT07147569 TAMBE Japan Post-Marketing Surveillance RECRUITING

Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

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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.

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