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FDA 510(k)

SURECAUT DIAMOND LASER KNIFE

K-Number: K983463 · 1998-12-11

ApplicantClinicon Corp.
Decision Date1998-12-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURECAUT DIAMOND LASER KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Clinicon Corp.. It received FDA 510(k) clearance on 1998-12-11 under 510(k) number K983463. 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 SURECAUT DIAMOND LASER KNIFE?

SURECAUT DIAMOND LASER KNIFE is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Clinicon Corp.. The 510(k) number is K983463.

When did SURECAUT DIAMOND LASER KNIFE receive FDA 510(k) clearance?

SURECAUT DIAMOND LASER KNIFE received FDA 510(k) clearance on 1998-12-11, under 510(k) number K983463.

Who is the listed applicant for SURECAUT DIAMOND LASER KNIFE?

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 SURECAUT DIAMOND LASER KNIFE?

The FDA product code for SURECAUT DIAMOND LASER KNIFE 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 TIPSK992472SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEMK970143C4

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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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