SmartBag (SmartPouch)— 510(k) K181643

Name: FDA 510(k) clearance K181643
Creator: U.S. Food and Drug Administration
Published: 2018-11-16

Substantially Equivalent

11 Health Technologies Limited

FDA 510(k) clearance K181643 for SmartBag (SmartPouch), Substantially Equivalent on 2018-11-16. Applicant: 11 Health Technologies Limited. Device class: 1.

Clearance details

Applicant: 11 Health Technologies Limited
Product code: Code EXB
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-22
Decision date: 2018-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Borehamwood, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.