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FDA 510(k)

CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS

K-Number: K014048 · 2002-02-11

ApplicantClinicon Corp.
Decision Date2002-02-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS is the device name listed in this FDA 510(k) record. The listed applicant is Clinicon Corp.. It received FDA 510(k) clearance on 2002-02-11 under 510(k) number K014048. 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 CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS?

CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS is a medical device that received FDA 510(k) clearance on 2002-02-11. The listed applicant is Clinicon Corp.. The 510(k) number is K014048.

When did CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS receive FDA 510(k) clearance?

CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS received FDA 510(k) clearance on 2002-02-11, under 510(k) number K014048.

Who is the listed applicant for CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS?

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 CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS?

The FDA product code for CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS is GEX. This falls under the Gastroenterology category.

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Other records listing Clinicon Corp. as applicant

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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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