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FDA 510(k)

NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM

K-Number: K902063 · 1990-06-29

ApplicantNiic U.S.A., Inc.
Decision Date1990-06-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Niic U.S.A., Inc.. It received FDA 510(k) clearance on 1990-06-29 under 510(k) number K902063. 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 NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM?

NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1990-06-29. The listed applicant is Niic U.S.A., Inc.. The 510(k) number is K902063.

When did NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1990-06-29, under 510(k) number K902063.

Who is the listed applicant for NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM?

The FDA 510(k) record lists Niic U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM?

The FDA product code for NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Niic U.S.A., Inc. 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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