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FDA 510(k)

Unistik® ShieldLock, Unistik VacuFlip

K-Number: K223854 · 2023-06-30

ApplicantOwen Mumford, Ltd.
Decision Date2023-06-30
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Unistik® ShieldLock, Unistik VacuFlip is a medical device manufactured by Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2023-06-30 under approval number K223854. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unistik® ShieldLock, Unistik VacuFlip?

Unistik® ShieldLock, Unistik VacuFlip is a medical device that received FDA 510(k) clearance on 2023-06-30. It is manufactured by Owen Mumford, Ltd.. The 510(k) number is K223854.

When was Unistik® ShieldLock, Unistik VacuFlip approved by the FDA?

Unistik® ShieldLock, Unistik VacuFlip received FDA 510(k) clearance on 2023-06-30, under approval number K223854.

What company makes Unistik® ShieldLock, Unistik VacuFlip?

Unistik® ShieldLock, Unistik VacuFlip is manufactured by Owen Mumford, Ltd..

What is the FDA product code for Unistik® ShieldLock, Unistik VacuFlip?

The FDA product code for Unistik® ShieldLock, Unistik VacuFlip is JKA.

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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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