FDA 510(k)

PureWay 1.4 Quart Sharps Collector

K-Number: K231484 · 2023-09-14

Decision Date2023-09-14

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PureWay 1.4 Quart Sharps Collector is the device name listed in this FDA 510(k) record. The listed applicant is Pureway Compliance, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K231484. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PureWay 1.4 Quart Sharps Collector?

PureWay 1.4 Quart Sharps Collector is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Pureway Compliance, Inc.. The 510(k) number is K231484.

When did PureWay 1.4 Quart Sharps Collector receive FDA 510(k) clearance?

PureWay 1.4 Quart Sharps Collector received FDA 510(k) clearance on 2023-09-14, under 510(k) number K231484.

Who is the listed applicant for PureWay 1.4 Quart Sharps Collector?

The FDA 510(k) record lists Pureway Compliance, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PureWay 1.4 Quart Sharps Collector?

The FDA product code for PureWay 1.4 Quart Sharps Collector is MMK.

Other records listing Pureway Compliance, Inc. 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.

K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

Related Devices (Code: MMK)

Official Source

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