Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SafeAir Smoke Evacuator compact

K-Number: K182224 · 2019-02-07

ApplicantLina Medical Aps
Decision Date2019-02-07
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SafeAir Smoke Evacuator compact is a medical device manufactured by Lina Medical Aps. It received FDA 510(k) clearance on 2019-02-07 under approval number K182224. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafeAir Smoke Evacuator compact?

SafeAir Smoke Evacuator compact is a medical device that received FDA 510(k) clearance on 2019-02-07. It is manufactured by Lina Medical Aps. The 510(k) number is K182224.

When was SafeAir Smoke Evacuator compact approved by the FDA?

SafeAir Smoke Evacuator compact received FDA 510(k) clearance on 2019-02-07, under approval number K182224.

What company makes SafeAir Smoke Evacuator compact?

SafeAir Smoke Evacuator compact is manufactured by Lina Medical Aps.

What is the FDA product code for SafeAir Smoke Evacuator compact?

The FDA product code for SafeAir Smoke Evacuator compact is FYD.

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 K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module K221085LiNA OperaScope Needle K223932SafeAir combi (SFR-combi-US) K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

View all 7 devices →

Related Devices (Code: FYD)

K163659Crystal VisionI.C Medical, Inc. K173108SmokleanSejong Medical Co., Ltd. K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc. K191328Megadyne Foot SwitchMegadyne Medical Products, Inc. K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc. K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.

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.

↑