510(k) Report

FDA applicant

Vibronics

Danville, CA1 decision1991–19912 recalls

FDA records 1 decision for Vibronics (Danville, CA) in 1991: 1 510(k) clearance. All are in product code KNW (Instrument, Biopsy). 2 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Vibronics since 2007.

Recalls per year

1in 2024

2019: 12024: 1
2007high 1 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Vibronics 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?

  • KNWInstrument, Biopsy1decision

Who builds on its devices?

Later devices cite its devices 3 times; 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.

  • K904987Vibronics Auto Core Biopsy Device (Acbd)Vibronics · 19913cite it

What has FDA decided for it lately?

  • K904987Vibronics Auto Core Biopsy Device (Acbd)Vibronics · 19912 recalls

The one decision as Vibronics →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K904987BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02…Jul 2, 2024Class II
  • K904987BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle…Dec 2, 2019Class II