510(k) Report

FDA applicant

Psk Connectors Pty, Ltd.

Kernersville, NC1 decision2000–20000 recalls

FDA records 1 decision for Psk Connectors Pty, Ltd. (Kernersville, NC) in 2000: 1 510(k) clearance. All are in product code FEB (Accessories, Cleaning, For Endoscope). 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 Psk Connectors Pty, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Psk Connectors Pty, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Psk Connectors Pty, Ltd. 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?

  • FEBAccessories, Cleaning, For Endoscope1decision

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.

  • K000216PSK Endoscope Cleaning SystemPsk Connectors Pty, Ltd. · 20001cites it

What has FDA decided for it lately?

  • K000216PSK Endoscope Cleaning SystemPsk Connectors Pty, Ltd. · 2000

The one decision as Psk Connectors Pty, Ltd. →