510(k) Report

FDA applicant

Apriomed AB

Uppsala, SE3 decisions2015–20200 recalls

FDA records 3 decisions for Apriomed AB (Uppsala, SE) from 2015 to 2020: 3 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and FCG (Biopsy Needle). Its devices cite 4 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 Apriomed AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2015: 12018: 12020: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Apriomed AB by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNWInstrument, Biopsy2decisions
  • FCGBiopsy Needle1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K193268APrioCore PlusApriomed AB · 2020
  • K181756Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial NeedleApriomed AB · 2018
  • K150625Morrison Steerable NeedleApriomed AB · 2015

All 3 as Apriomed AB →