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FDA 510(k)

SECULOK™ ACP System

K-Number: K190053 · 2019-02-01

ApplicantU&I Corporation
Decision Date2019-02-01
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SECULOK™ ACP System is the device name listed in this FDA 510(k) record. The listed applicant is U&I Corporation. It received FDA 510(k) clearance on 2019-02-01 under 510(k) 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. The listed applicant is U&I Corporation. The 510(k) number is K190053.

When did SECULOK™ ACP System receive FDA 510(k) clearance?

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

Who is the listed applicant for SECULOK™ ACP System?

The FDA 510(k) record lists U&I Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SECULOK™ ACP System?

The FDA product code for SECULOK™ ACP System is KWQ.

Other records listing U&I Corporation as applicant

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Related Devices (Code: KWQ)

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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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