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FDA 510(k)

Stela Capsule System

K-Number: K222583 · 2022-10-28

ApplicantSdi Limited
Decision Date2022-10-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Stela Capsule System is a medical device manufactured by Sdi Limited. It received FDA 510(k) clearance on 2022-10-28 under approval number K222583. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stela Capsule System?

Stela Capsule System is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by Sdi Limited. The 510(k) number is K222583.

When was Stela Capsule System approved by the FDA?

Stela Capsule System received FDA 510(k) clearance on 2022-10-28, under approval number K222583.

What company makes Stela Capsule System?

Stela Capsule System is manufactured by Sdi Limited.

What is the FDA product code for Stela Capsule System?

The FDA product code for Stela Capsule System is EBF.

Related Clinical Trials

NCT07587437 Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery 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 NCT06748911 Navicam for Detection of Barrett's Esophagus RECRUITING NCT02910479 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius) COMPLETED

Other Devices by Sdi Limited

K172047Riva Star K191656Zipbond K222581Stela Automix System K214118Riva Cem Automix

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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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