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FDA 510(k)

FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM

K-Number: K880061 · 1988-06-20

ApplicantAbbott Laboratories
Decision Date1988-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1988-06-20 under 510(k) number K880061. 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 FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM?

FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1988-06-20. The listed applicant is Abbott Laboratories. The 510(k) number is K880061.

When did FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1988-06-20, under 510(k) number K880061.

Who is the listed applicant for FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM?

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

What is the FDA product code for FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM?

The FDA product code for FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM 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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