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FDA 510(k)

EPY-50

K-Number: K020513 · 2002-05-16

ApplicantDdc Technologies, Inc.
Decision Date2002-05-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPY-50 is the device name listed in this FDA 510(k) record. The listed applicant is Ddc Technologies, Inc.. It received FDA 510(k) clearance on 2002-05-16 under 510(k) number K020513. 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 EPY-50?

EPY-50 is a medical device that received FDA 510(k) clearance on 2002-05-16. The listed applicant is Ddc Technologies, Inc.. The 510(k) number is K020513.

When did EPY-50 receive FDA 510(k) clearance?

EPY-50 received FDA 510(k) clearance on 2002-05-16, under 510(k) number K020513.

Who is the listed applicant for EPY-50?

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

What is the FDA product code for EPY-50?

The FDA product code for EPY-50 is GEX. This falls under the Gastroenterology category.

Other records listing Ddc Technologies, Inc. as applicant

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.

K253765VANISH PROK040055POLYLASE LPK010715AL-40

Related Devices (Code: GEX)

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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.

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