Medical Device Manufacturer · US , Chapel Hill , NC

Lina Medical Aps

16 submissions · 16 cleared · Since 2006
16
Total
16
Cleared
0
Denied

Lina Medical Aps — FDA 510(k) Submissions

Lina Medical Aps has submitted 16 FDA 510(k) premarket notifications since 2006, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Hysteroscope (and Accessories), Coagulator-cutter, Endoscopic, Unipolar (and Accessories), Laparoscope, Gynecologic (and Accessories), Coagulator-cutter, Endoscopic, Bipolar (and Accessories) . Use the specialty filter in the sidebar to narrow results.

16 devices
1–16 of 16
LiNA CystoVu? HD (CYV-100-5; CYV-101-5); LiNA ScopeVu? (SCP-100-1)
K240227 · FAJ Cystoscope And... · Gastroenterology & Urology
Aug 2024 209d
SafeAir combi (SFR-combi-US)
K223932 · GEI Electrosurgical, Cutting... · General Hospital
Apr 2023 117d
LiNA OperaScope Needle
K221085 · FBK Endoscopic Injection... · Obstetrics & Gynecology
Sep 2022 142d
LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module
K193007 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Jan 2020 81d
SafeAir Smoke Evacuator compact
K182224 · FYD Apparatus, Exhaust, Surgical · General Hospital
Feb 2019 175d
SafeAir Telescopic Smoke Pencil
K182354 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2018 107d
LiNA 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
K171113 · HIH Hysteroscope (and... · Obstetrics & Gynecology
Jan 2018 265d
SafeAir Smoke Pencil
K143145 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2014 31d
LiNA PowerBlade Plus HC
K142757 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2014 28d
LiNA SafeAir Smoke Pencil
K142538 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2014 27d
LINA GOLD LOOP HC
K132135 · KNF Coagulator-cutter,... · Obstetrics & Gynecology
Jan 2014 205d
LINA POWERBLADE PLUS
K132837 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2013 100d
LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE
K130305 · HIN Coagulator-cutter,... · Obstetrics & Gynecology
Jul 2013 169d
LINA XCISE MODEL MOR-1515
K101458 · HET Laparoscope, Gynecologic... · Obstetrics & Gynecology
Mar 2011 289d
LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
K070315 · KNF Coagulator-cutter,... · Obstetrics & Gynecology
Oct 2007 271d
LINA POWERBLADE, MODEL 5005,5005-E,5005-C,5005-150,5000-C-150,5005-E-C-150,5005-420,5005-C-420,5005-E-420,5005-E-C-420,
K063025 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2006 60d
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