LiNA OperaScope Needle
K-Number: K221085 · 2022-09-02
ApplicantLina Medical Aps
Decision Date2022-09-02
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
LiNA OperaScope Needle is a medical device manufactured by Lina Medical Aps. It received FDA 510(k) clearance on 2022-09-02 under approval number K221085. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
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. It is manufactured by Lina Medical Aps. The 510(k) number is K221085.
When was LiNA OperaScope Needle approved by the FDA?
LiNA OperaScope Needle received FDA 510(k) clearance on 2022-09-02, under approval number K221085.
What company makes LiNA OperaScope Needle?
LiNA OperaScope Needle is manufactured by Lina Medical Aps.
What is the FDA product code for LiNA OperaScope Needle?
The FDA product code for LiNA OperaScope Needle is FBK.
Other Devices by Lina Medical Aps
K182354SafeAir Telescopic Smoke Pencil
K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module
K182224SafeAir Smoke Evacuator compact
K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
K223932SafeAir combi (SFR-combi-US)
K240227LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
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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.