510(k) Report

FDA applicant

Aus Systems Pty, Ltd.

Clearwater, FL1 decision2006–20060 recalls

FDA records 1 decision for Aus Systems Pty, Ltd. (Clearwater, FL) in 2006: 1 510(k) clearance. All are in product code FCK (Instrument, Biopsy, Suction). Its devices cite 1 predicate, 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 Aus Systems Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Aus Systems Pty, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Aus Systems Pty, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Aus Systems Pty, Ltd.’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?

  • FCKInstrument, Biopsy, Suction1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K062159RB12 Suction Rectal Biopsy SystemAus Systems Pty, Ltd. · 2006

The one decision as Aus Systems Pty, Ltd. →