LINA XCISE MODEL MOR-1515— 510(k) K101458

Substantially Equivalent

Lina Medical Aps

FDA 510(k) clearance K101458 for LINA XCISE MODEL MOR-1515, Substantially Equivalent on 2011-03-11. Applicant: Lina Medical Aps.

Clearance details

Applicant: Lina Medical Aps
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2010-05-26
Decision date: 2011-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chapel Hill, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.