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FDA 510(k)

SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM

K-Number: K992472 · 1999-09-08

ApplicantClinicon Corp.
Decision Date1999-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clinicon Corp.. It received FDA 510(k) clearance on 1999-09-08 under 510(k) number K992472. 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 SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM?

SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-08. The listed applicant is Clinicon Corp.. The 510(k) number is K992472.

When did SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM receive FDA 510(k) clearance?

SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM received FDA 510(k) clearance on 1999-09-08, under 510(k) number K992472.

Who is the listed applicant for SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM?

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

What is the FDA product code for SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM?

The FDA product code for SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Clinicon Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121580SURELASE CO2 LASER SYSTEMK063698CO2 LASER SYSTEM, MODEL C-LASK014236CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIESK014048CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPSK983463SURECAUT DIAMOND LASER KNIFEK970143C4

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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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