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FDA 510(k)

QUARTZ FIBER CATHETERS AND SURGICAL TIPS

K-Number: K900144 · 1990-02-09

ApplicantPfizer Laser Systems
Decision Date1990-02-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

QUARTZ FIBER CATHETERS AND SURGICAL TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer Laser Systems. It received FDA 510(k) clearance on 1990-02-09 under 510(k) number K900144. 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 QUARTZ FIBER CATHETERS AND SURGICAL TIPS?

QUARTZ FIBER CATHETERS AND SURGICAL TIPS is a medical device that received FDA 510(k) clearance on 1990-02-09. The listed applicant is Pfizer Laser Systems. The 510(k) number is K900144.

When did QUARTZ FIBER CATHETERS AND SURGICAL TIPS receive FDA 510(k) clearance?

QUARTZ FIBER CATHETERS AND SURGICAL TIPS received FDA 510(k) clearance on 1990-02-09, under 510(k) number K900144.

Who is the listed applicant for QUARTZ FIBER CATHETERS AND SURGICAL TIPS?

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

What is the FDA product code for QUARTZ FIBER CATHETERS AND SURGICAL TIPS?

The FDA product code for QUARTZ FIBER CATHETERS AND SURGICAL TIPS is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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