LiNA OperaScope Needle— 510(k) K221085

Substantially Equivalent

Lina Medical Aps

FDA 510(k) clearance K221085 for LiNA OperaScope Needle, Substantially Equivalent on 2022-09-02. Applicant: Lina Medical Aps.

Clearance details

Applicant: Lina Medical Aps
Product code: Code FBK
Advisory panel: Gastroenterology, Urology
Date received: 2022-04-13
Decision date: 2022-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glostrup, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code FBK

product code FBK

Other: 1
Total: 1

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.