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FDA 510(k)

DIOMED DELTA 25

K-Number: K063828 · 2007-01-25

ApplicantDiomed, Ltd.
Decision Date2007-01-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIOMED DELTA 25 is the device name listed in this FDA 510(k) record. The listed applicant is Diomed, Ltd.. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K063828. 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 DIOMED DELTA 25?

DIOMED DELTA 25 is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Diomed, Ltd.. The 510(k) number is K063828.

When did DIOMED DELTA 25 receive FDA 510(k) clearance?

DIOMED DELTA 25 received FDA 510(k) clearance on 2007-01-25, under 510(k) number K063828.

Who is the listed applicant for DIOMED DELTA 25?

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

What is the FDA product code for DIOMED DELTA 25?

The FDA product code for DIOMED DELTA 25 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Diomed, Ltd. 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.

K051996DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30K012398DIOMED 15 DIODE LASER

Related Devices (Code: GEX)

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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