510(k) Report

FDA applicant

Lina Medical Cml Aps

Glostrup, DK1 decision2003–20030 recalls

FDA records 1 decision for Lina Medical Cml Aps (Glostrup, DK) in 2003: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

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

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Lina Medical Cml Aps since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K030422Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 20031cites it

What has FDA decided for it lately?

  • K030422Lina-Bag, Models LB-60, LB-100Lina Medical Cml Aps · 2003

The one decision as Lina Medical Cml Aps →

Other applicant names beginning “Lina”

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

Lina Medical Aps 16