510(k) Report

FDA applicant

Lina Medical Aps

Glostrup, DK16 decisions2006–202415 recalls

FDA records 16 decisions for Lina Medical Aps (Glostrup, DK) from 2006 to 2024: 16 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HIH (Hysteroscope (And Accessories)). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 104 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 6 of them its own earlier devices. 15 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Lina Medical Aps’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 12011: 12013: 22014: 42018: 22019: 12020: 12022: 12023: 12024: 1
2007high 4 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2025

2009: 32020: 42024: 72025: 1
2007high 7 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lina Medical Aps by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lina Medical Aps’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories7decisions
  • HIHHysteroscope (And Accessories)2decisions
  • KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)2decisions
  • FYDApparatus, Exhaust, Surgical1decision
  • FAJCystoscope And Accessories, Flexible/Rigid1decision
  • HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)1decision

Also: HET (1), FBK (1).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 104 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 21 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070315Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 20075cite it
  • K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board…Lina Medical Aps · 20182cite it
  • K132837Lina Powerblade PlusLina Medical Aps · 20131cites it
  • K142538LiNA SafeAir Smoke PencilLina Medical Aps · 20141cites it
  • K143145SafeAir Smoke PencilLina Medical Aps · 20141cites it
  • K101458Lina Xcise Model Mor-1515Lina Medical Aps · 20111cites it

What has FDA decided for it lately?

  • K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps · 2024
  • K223932SafeAir combi (SFR-combi-US)Lina Medical Aps · 2023
  • K221085LiNA OperaScope NeedleLina Medical Aps · 2022
  • K193007LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording ModuleLina Medical Aps · 2020
  • K182224SafeAir Smoke Evacuator compactLina Medical Aps · 2019
  • K182354SafeAir Telescopic Smoke PencilLina Medical Aps · 20184 recalls
  • K171113LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board…Lina Medical Aps · 2018
  • K143145SafeAir Smoke PencilLina Medical Aps · 20148 recalls

All 16 as Lina Medical Aps →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K143145stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal…Jan 8, 2025Class II
  • K143145100V Neptune 3 Rover Japanese (0703-003-000) 120V Neptune S Rover (0711-001-000) 230V…Dec 3, 2024Class II
  • K143145Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch…Oct 4, 2024Class II
  • K143145Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed…Oct 4, 2024Class II
  • K143145Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm -…Oct 4, 2024Class II
  • K143145Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button -…Oct 4, 2024Class II

Other applicant names beginning “Lina”

FDA records each applicant name separately; these may or may not be the same firm.

Lina Medical Cml Aps 1