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FDA 510(k)

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare

K-Number: K190512 · 2019-11-22

ApplicantIntelligent Endoscopy
Decision Date2019-11-22
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is a medical device manufactured by Intelligent Endoscopy. It received FDA 510(k) clearance on 2019-11-22 under approval number K190512. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by Intelligent Endoscopy. The 510(k) number is K190512.

When was SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare approved by the FDA?

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare received FDA 510(k) clearance on 2019-11-22, under approval number K190512.

What company makes SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?

SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is manufactured by Intelligent Endoscopy.

What is the FDA product code for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare?

The FDA product code for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare is FDI.

Related Clinical Trials

NCT05822895 Review of the Impact of a Computer-aided Real-time Polyp Detection System on Adult Colonoscopy RECRUITING

Related Devices (Code: FDI)

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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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