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)

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

K-Number: K222734 · 2022-11-08

ApplicantDiversatek Healthcare
Decision Date2022-11-08
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Diversatek Healthcare. It received FDA 510(k) clearance on 2022-11-08 under 510(k) number K222734. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is a medical device that received FDA 510(k) clearance on 2022-11-08. The listed applicant is Diversatek Healthcare. The 510(k) number is K222734.

When did Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing receive FDA 510(k) clearance?

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing received FDA 510(k) clearance on 2022-11-08, under 510(k) number K222734.

Who is the listed applicant for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

The FDA 510(k) record lists Diversatek Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

The FDA product code for Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is OCX.

Other records listing Diversatek Healthcare as applicant

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.

K230056MiVu™ Esophageal Endo CapK190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

Related Devices (Code: OCX)

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.

K251986AUXILIARY WATER TUBE MAJ-855Olympus Medical Systems CorporationK251997Single-Use Biopsy Valve (MAJ-1555)Olympus Medical Systems CorporationK242586ArgoCap (200.52)Ovesco Endoscopy AGK241704Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd.K242357Water Container (MAJ-901); Water Container (MAJ-902)Olympus Medical Systems CorporationK241874Aspiration Catheter (2189)Hobbs Medical, 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.

↑