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FDA 510(k)

C4

K-Number: K970143 · 1997-10-29

ApplicantClinicon Corp.
Decision Date1997-10-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C4 is the device name listed in this FDA 510(k) record. The listed applicant is Clinicon Corp.. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K970143. 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 C4?

C4 is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Clinicon Corp.. The 510(k) number is K970143.

When did C4 receive FDA 510(k) clearance?

C4 received FDA 510(k) clearance on 1997-10-29, under 510(k) number K970143.

Who is the listed applicant for C4?

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 C4?

The FDA product code for C4 is GEX. This falls under the Gastroenterology category.

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 TIPSK992472SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEMK983463SURECAUT DIAMOND LASER KNIFE

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Related Devices (Code: GEX)

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.

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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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