SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare— 510(k) K190512

Name: FDA 510(k) clearance K190512
Creator: U.S. Food and Drug Administration
Published: 2019-11-22

Substantially Equivalent

Intelligent Endoscopy

FDA 510(k) clearance K190512 for SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare, Substantially Equivalent on 2019-11-22. Applicant: Intelligent Endoscopy. Device class: 2.

Clearance details

Applicant: Intelligent Endoscopy
Product code: Code FDI
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2019-03-01
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clemmons, NC, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.