Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing— 510(k) K222734

Name: FDA 510(k) clearance K222734
Creator: U.S. Food and Drug Administration
Published: 2022-11-08

Substantially Equivalent

Diversatek Healthcare

FDA 510(k) clearance K222734 for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing, Substantially Equivalent on 2022-11-08. Applicant: Diversatek Healthcare. Device class: 2.

Clearance details

Applicant: Diversatek Healthcare
Product code: Code OCX
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-09
Decision date: 2022-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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K251986 — AUXILIARY WATER TUBE MAJ-8552025-09-26
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K241704 — Endoscopic Water Pump2025-03-20
K242357 — Water Container (MAJ-901); Water Container (MAJ-902)2024-10-07

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