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FDA 510(k)

MICROLASE CO2 LASER MICROMANIPULATOR

K-Number: K891126 · 1989-03-17

ApplicantXimed Medical Systems
Decision Date1989-03-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROLASE CO2 LASER MICROMANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ximed Medical Systems. It received FDA 510(k) clearance on 1989-03-17 under 510(k) number K891126. 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 MICROLASE CO2 LASER MICROMANIPULATOR?

MICROLASE CO2 LASER MICROMANIPULATOR is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Ximed Medical Systems. The 510(k) number is K891126.

When did MICROLASE CO2 LASER MICROMANIPULATOR receive FDA 510(k) clearance?

MICROLASE CO2 LASER MICROMANIPULATOR received FDA 510(k) clearance on 1989-03-17, under 510(k) number K891126.

Who is the listed applicant for MICROLASE CO2 LASER MICROMANIPULATOR?

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

What is the FDA product code for MICROLASE CO2 LASER MICROMANIPULATOR?

The FDA product code for MICROLASE CO2 LASER MICROMANIPULATOR is GEX. This falls under the Gastroenterology category.

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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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