LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module— 510(k) K193007

Substantially Equivalent

Lina Medical Aps

FDA 510(k) clearance K193007 for LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module, Substantially Equivalent on 2020-01-17. Applicant: Lina Medical Aps.

Clearance details

Applicant: Lina Medical Aps
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2019-10-28
Decision date: 2020-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glostrup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.