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FDA 510(k)

ACTIV™ Cap

K-Number: K223914 · 2024-04-05

Decision Date2024-04-05
Product CodeQBP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACTIV™ Cap is the device name listed in this FDA 510(k) record. The listed applicant is Cleansite Medical, Inc.. It received FDA 510(k) clearance on 2024-04-05 under 510(k) number K223914. The device is classified under product code QBP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTIV™ Cap?

ACTIV™ Cap is a medical device that received FDA 510(k) clearance on 2024-04-05. The listed applicant is Cleansite Medical, Inc.. The 510(k) number is K223914.

When did ACTIV™ Cap receive FDA 510(k) clearance?

ACTIV™ Cap received FDA 510(k) clearance on 2024-04-05, under 510(k) number K223914.

Who is the listed applicant for ACTIV™ Cap?

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

What is the FDA product code for ACTIV™ Cap?

The FDA product code for ACTIV™ Cap is QBP.

Related Devices (Code: QBP)

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.

Official Source

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