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FDA 510(k)

ACU-GUARD

K-Number: K915000 · 1992-01-27

ApplicantAcuderm, Inc.
Decision Date1992-01-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACU-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Acuderm, Inc.. It received FDA 510(k) clearance on 1992-01-27 under 510(k) number K915000. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-GUARD?

ACU-GUARD is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Acuderm, Inc.. The 510(k) number is K915000.

When did ACU-GUARD receive FDA 510(k) clearance?

ACU-GUARD received FDA 510(k) clearance on 1992-01-27, under 510(k) number K915000.

Who is the listed applicant for ACU-GUARD?

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

What is the FDA product code for ACU-GUARD?

The FDA product code for ACU-GUARD is GEX. This falls under the Gastroenterology category.

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Other records listing Acuderm, Inc. as applicant

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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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