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FDA 510(k)

COM-PATCH

K-Number: K012140 · 2001-10-05

ApplicantApex Medical Corp.
Decision Date2001-10-05
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COM-PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Apex Medical Corp.. It received FDA 510(k) clearance on 2001-10-05 under 510(k) number K012140. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COM-PATCH?

COM-PATCH is a medical device that received FDA 510(k) clearance on 2001-10-05. The listed applicant is Apex Medical Corp.. The 510(k) number is K012140.

When did COM-PATCH receive FDA 510(k) clearance?

COM-PATCH received FDA 510(k) clearance on 2001-10-05, under 510(k) number K012140.

Who is the listed applicant for COM-PATCH?

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

What is the FDA product code for COM-PATCH?

The FDA product code for COM-PATCH is GXY.

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Other records listing Apex Medical Corp. as applicant

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Related Devices (Code: GXY)

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.

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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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