LiNA OperaScope Needle
K-Number: K221085 · 2022-09-02
Device Summary
Frequently Asked Questions
What is the LiNA OperaScope Needle?
LiNA OperaScope Needle is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Lina Medical Aps. The 510(k) number is K221085.
When did LiNA OperaScope Needle receive FDA 510(k) clearance?
LiNA OperaScope Needle received FDA 510(k) clearance on 2022-09-02, under 510(k) number K221085.
Who is the listed applicant for LiNA OperaScope Needle?
The FDA 510(k) record lists Lina Medical Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LiNA OperaScope Needle?
The FDA product code for LiNA OperaScope Needle is FBK.
Other records listing Lina Medical Aps as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: FBK)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.