Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PSK ENDOSCOPE CLEANING SYSTEM

K-Number: K000216 · 2000-05-09

ApplicantPsk Connectors Pty, Ltd.
Decision Date2000-05-09
Product CodeFEB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PSK ENDOSCOPE CLEANING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Psk Connectors Pty, Ltd.. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K000216. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PSK ENDOSCOPE CLEANING SYSTEM?

PSK ENDOSCOPE CLEANING SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is Psk Connectors Pty, Ltd.. The 510(k) number is K000216.

When did PSK ENDOSCOPE CLEANING SYSTEM receive FDA 510(k) clearance?

PSK ENDOSCOPE CLEANING SYSTEM received FDA 510(k) clearance on 2000-05-09, under 510(k) number K000216.

Who is the listed applicant for PSK ENDOSCOPE CLEANING SYSTEM?

The FDA 510(k) record lists Psk Connectors Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PSK ENDOSCOPE CLEANING SYSTEM?

The FDA product code for PSK ENDOSCOPE CLEANING SYSTEM is FEB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: FEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241168System 83 Revolve Endoscope Washer/DisinfectorWassenburg Medical, Inc.K243433enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemSTERIS CorporationK230930enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemSTERIS CorporationK213833SCOPE BUDDY PLUS Endoscope Flushing AidMedivators, Inc.K201920Endoscope Reprocessor OER-EliteOlympus Medical Systems Corp.K173590System 83 Plus Washer/DisinfectorCustom Ultrasonics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑