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FDA 510(k)

METALASER VASCULASE

K-Number: K883541 · 1988-11-04

ApplicantMetatech Corp.
Decision Date1988-11-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

METALASER VASCULASE is the device name listed in this FDA 510(k) record. The listed applicant is Metatech Corp.. It received FDA 510(k) clearance on 1988-11-04 under 510(k) number K883541. 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 METALASER VASCULASE?

METALASER VASCULASE is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Metatech Corp.. The 510(k) number is K883541.

When did METALASER VASCULASE receive FDA 510(k) clearance?

METALASER VASCULASE received FDA 510(k) clearance on 1988-11-04, under 510(k) number K883541.

Who is the listed applicant for METALASER VASCULASE?

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

What is the FDA product code for METALASER VASCULASE?

The FDA product code for METALASER VASCULASE is GEX. This falls under the Gastroenterology category.

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Other records listing Metatech Corp. 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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