PSK ENDOSCOPE CLEANING SYSTEM— 510(k) K000216

Substantially Equivalent

Psk Connectors Pty, Ltd.

FDA 510(k) clearance K000216 for PSK ENDOSCOPE CLEANING SYSTEM, Substantially Equivalent on 2000-05-09. Applicant: Psk Connectors Pty, Ltd..

Clearance details

Applicant: Psk Connectors Pty, Ltd.
Product code: Code FEB
Advisory panel: Gastroenterology, Urology
Date received: 2000-01-24
Decision date: 2000-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kernersville, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEB

product code FEB

Malfunction: 3,879
Total: 3,879

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.