Xtreme-Loop— 510(k) K191053

Name: FDA 510(k) clearance K191053
Creator: U.S. Food and Drug Administration
Published: 2019-07-17

Substantially Equivalent

Xiros, Ltd.

FDA 510(k) clearance K191053 for Xtreme-Loop, Substantially Equivalent on 2019-07-17. Applicant: Xiros, Ltd.. Device class: 2.

Clearance details

Applicant: Xiros, Ltd.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2019-04-19
Decision date: 2019-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.