LiNA Medical Inc
Root D4 Luzern, CH
LINA MEDICAL INC appears in FDA device records in Root D4 Luzern, CH. FDA records list 16 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for LiNA Medical Inc between 2006 and 2024. The busiest year on record is 2014, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| 2013 | 2 |
| 2014 | 4 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240227 | LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) | FAJ | Substantially Equivalent | |
| K223932 | SafeAir combi (SFR-combi-US) | GEI | Substantially Equivalent | |
| K221085 | LiNA OperaScope Needle | FBK | Substantially Equivalent | |
| K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module | HIH | Substantially Equivalent | |
| K182224 | SafeAir Smoke Evacuator compact | FYD | Substantially Equivalent | |
| K182354 | SafeAir Telescopic Smoke Pencil | GEI | Substantially Equivalent | |
| K171113 | 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 | HIH | Substantially Equivalent | |
| K143145 | SafeAir Smoke Pencil | GEI | Substantially Equivalent | |
| K142757 | LiNA PowerBlade Plus HC | GEI | Substantially Equivalent | |
| K142538 | LiNA SafeAir Smoke Pencil | GEI | Substantially Equivalent | |
| K132135 | LINA GOLD LOOP HC | KNF | Substantially Equivalent | |
| K132837 | LINA POWERBLADE PLUS | GEI | Substantially Equivalent | |
| K130305 | LINA BIPOLAR LOOP; STANDARD SIZE, LARGE SIZE, EXTRA LARGE SIZE | HIN | Substantially Equivalent | |
| K101458 | LINA XCISE MODEL MOR-1515 | HET | Substantially Equivalent | |
| K070315 | LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | KNF | Substantially Equivalent | |
| 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, | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008755118 | 3008755118 | LINA MEDICAL INC | 1856 Corporate Drive, suite 135, Norcross, GA 30093 US | 2026 | No device listings on this registration |
| 3008693678 | 3008693678 | LiNA Medical AG | Platz 3, Root D4 Luzern 6039 CH | 2026 | and 6 more, listed in full below |
| 3027454635 | 3027454635 | LiNA Medical ApS | Naerum Hovedgade 10B, Naerum Hovedstaden 2850 DK | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- FYDApparatus, Exhaust, Surgical
- HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- HEWCuldoscope (And Accessories)
- FAJCystoscope And Accessories, Flexible/Rigid
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt
- FBKEndoscopic Injection Needle, Gastroenterology-Urology
- PXUFluid Drainage Tray
- HTDForceps
- FCLForceps, Biopsy, Non-Electric
- GDGHook, Surgical, General & Plastic Surgery
- HIHHysteroscope (And Accessories)
- NWWHysteroscope Accessories
- HETLaparoscope, Gynecologic (And Accessories)
- GADRetractor
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2690-2011 | 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 Division. | Potential for the LiNA Loop to break during operating procedure. | Terminated | ||
| Z-2689-2011 | 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 Division. | Potential for the LiNA Loop to break during operating procedure. | Terminated | ||
| Z-2688-2011 | 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 Division. | Potential for the LiNA Loop to break during operating procedure. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain