510(k) Report

FDA applicant

Berni Farns Incorporated

Fernandina Beach, FL1 decision2012–20120 recalls

FDA records 1 decision for Berni Farns Incorporated (Fernandina Beach, FL) in 2012: 1 510(k) clearance. All are in product code KNW (Instrument, Biopsy). 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 Berni Farns Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Berni Farns Incorporated by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KNWInstrument, Biopsy1decision

What has FDA decided for it lately?

  • K120189BonetrapBerni Farns Incorporated · 2012

The one decision as Berni Farns Incorporated →