FDA 510(k)

SECULOK ACP System

K-Number: K190053 · 2019-02-01

Decision Date2019-02-01

Product CodeKWQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SECULOK ACP System is a medical device manufactured by U&I Corporation. It received FDA 510(k) clearance on 2019-02-01 under approval number K190053. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECULOK ACP System?

SECULOK ACP System is a medical device that received FDA 510(k) clearance on 2019-02-01. It is manufactured by U&I Corporation. The 510(k) number is K190053.

When was SECULOK ACP System approved by the FDA?

SECULOK ACP System received FDA 510(k) clearance on 2019-02-01, under approval number K190053.

What company makes SECULOK ACP System?

SECULOK ACP System is manufactured by U&I Corporation.

What is the FDA product code for SECULOK ACP System?

The FDA product code for SECULOK ACP System is KWQ.

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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.