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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 a medical device manufactured by Diversatek Healthcare. It received FDA 510(k) clearance on 2022-11-08 under approval 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. It is manufactured by Diversatek Healthcare. The 510(k) number is K222734.

When was Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing approved by the FDA?

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

What company makes Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing?

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing is manufactured by Diversatek Healthcare.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 42043129 Iatrogenic Microplastic Exposure: A Possible and Underrecognized Healthcare-Associated Exposure Framework in Human Medicotoxicological Risk. Toxics (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026)

Other Devices by Diversatek Healthcare

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Related Devices (Code: OCX)

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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.

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