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FDA 510(k)

EPIGUARD

K-Number: K050188 · 2005-04-27

ApplicantEpisafe Medical Devices, Ltd.
Decision Date2005-04-27
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EPIGUARD is the device name listed in this FDA 510(k) record. The listed applicant is Episafe Medical Devices, Ltd.. It received FDA 510(k) clearance on 2005-04-27 under 510(k) number K050188. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIGUARD?

EPIGUARD is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Episafe Medical Devices, Ltd.. The 510(k) number is K050188.

When did EPIGUARD receive FDA 510(k) clearance?

EPIGUARD received FDA 510(k) clearance on 2005-04-27, under 510(k) number K050188.

Who is the listed applicant for EPIGUARD?

The FDA 510(k) record lists Episafe Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIGUARD?

The FDA product code for EPIGUARD is JXL.

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Related Devices (Code: JXL)

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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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