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FDA 510(k)

ACCUCURE 3000

K-Number: K943411 · 1995-04-25

ApplicantLasermed
Decision Date1995-04-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCUCURE 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Lasermed. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K943411. 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 ACCUCURE 3000?

ACCUCURE 3000 is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Lasermed. The 510(k) number is K943411.

When did ACCUCURE 3000 receive FDA 510(k) clearance?

ACCUCURE 3000 received FDA 510(k) clearance on 1995-04-25, under 510(k) number K943411.

Who is the listed applicant for ACCUCURE 3000?

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

What is the FDA product code for ACCUCURE 3000?

The FDA product code for ACCUCURE 3000 is GEX. This falls under the Gastroenterology category.

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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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