510(k) Report

FDA applicant

Uni-Quatro Industries Canada, Inc.

Niagara Falls, Ontario, CA3 decisions1991–19941 recall

FDA records 3 decisions for Uni-Quatro Industries Canada, Inc. (Niagara Falls, Ontario, CA) from 1991 to 1994: 3 510(k) clearances. Most are in product codes FCG (Biopsy Needle) and KNW (Instrument, Biopsy). 1 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 Uni-Quatro Industries Canada, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Uni-Quatro Industries Canada, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Uni-Quatro Industries Canada, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • FCGBiopsy Needle2decisions
  • KNWInstrument, Biopsy1decision

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.

  • K905556High Speed Core Cut Biopsy GunUni-Quatro Industries Canada, Inc. · 19911cites it

What has FDA decided for it lately?

  • K915801Bip-Coax-SystemUni-Quatro Industries Canada, Inc. · 19941 recall
  • K905557CCC Crown-Core-Cut-NeedleUni-Quatro Industries Canada, Inc. · 1991
  • K905556High Speed Core Cut Biopsy GunUni-Quatro Industries Canada, Inc. · 1991

All 3 as Uni-Quatro Industries Canada, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K915801Bard TruGuide Coxail Biopsy Needle with Depth Stop and additional Blunt Tip Stylet…May 1, 2006