Company · DK
Lina Medical Aps
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2024. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 5 |
| HIH | Hysteroscope (And Accessories) | 2 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 |
| FYD | Apparatus, Exhaust, Surgical | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 22, 2024 | K240227 | LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1) Lina Medical Aps, DK | FAJ |
| Apr 26, 2023 | K223932 | SafeAir combi (SFR-combi-US) Lina Medical Aps, DK | GEI |
| Sep 2, 2022 | K221085 | LiNA OperaScope Needle Lina Medical Aps, DK | FBK |
| Jan 17, 2020 | K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module Lina Medical Aps, DK | HIH |
| Feb 7, 2019 | K182224 | SafeAir Smoke Evacuator compact Lina Medical Aps, PL | FYD |
| Dec 14, 2018 | K182354 | SafeAir Telescopic Smoke Pencil Lina Medical Aps, DK | GEI |
| Jan 4, 2018 | K171113 | LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, Lina Medical Aps, DK | HIH |
| Dec 4, 2014 | K143145 | SafeAir Smoke Pencil Lina Medical Aps, DK | GEI |
| Oct 23, 2014 | K142757 | LiNA PowerBlade Plus HC Lina Medical Aps, DK | GEI |
| Oct 6, 2014 | K142538 | LiNA SafeAir Smoke Pencil Lina Medical Aps, DK | GEI |
| Jan 31, 2014 | K132135 | LINA GOLD LOOP HC Lina Medical Aps | KNF |
| Dec 19, 2013 | K132837 | LINA POWERBLADE PLUS Lina Medical Aps | GEI |
| Jul 24, 2013 | K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE Lina Medical Aps | HIN |
| Mar 11, 2011 | K101458 | LINA XCISE MODEL MOR-1515 Lina Medical Aps | HET |
| Oct 30, 2007 | K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 Lina Medical Aps | KNF |
| Dec 1, 2006 | K063025 | 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, Lina Medical Aps | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2011 | LINA Medical ApS LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Di Terminated |
KNF | K070315 |
| Jun 28, 2011 | LINA Medical ApS LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery D Terminated |
KNF | K070315 |
| Jun 28, 2011 | LINA Medical ApS LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery D Terminated |
KNF | K070315 |