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FDA 510(k)

LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS

K-Number: K900463 · 1990-03-22

ApplicantXimed Medical Systems
Decision Date1990-03-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS 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 1990-03-22 under 510(k) number K900463. 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 LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS?

LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS is a medical device that received FDA 510(k) clearance on 1990-03-22. The listed applicant is Ximed Medical Systems. The 510(k) number is K900463.

When did LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS receive FDA 510(k) clearance?

LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS received FDA 510(k) clearance on 1990-03-22, under 510(k) number K900463.

Who is the listed applicant for LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS?

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 LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS?

The FDA product code for LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS 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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