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FDA 510(k)

MODEL: IR205 ARTICULATED SURGICAL LASER

K-Number: K895581 · 1989-12-13

ApplicantNiic U.S.A., Inc.
Decision Date1989-12-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL: IR205 ARTICULATED SURGICAL LASER 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 1989-12-13 under 510(k) number K895581. 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 MODEL: IR205 ARTICULATED SURGICAL LASER?

MODEL: IR205 ARTICULATED SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Niic U.S.A., Inc.. The 510(k) number is K895581.

When did MODEL: IR205 ARTICULATED SURGICAL LASER receive FDA 510(k) clearance?

MODEL: IR205 ARTICULATED SURGICAL LASER received FDA 510(k) clearance on 1989-12-13, under 510(k) number K895581.

Who is the listed applicant for MODEL: IR205 ARTICULATED SURGICAL LASER?

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 MODEL: IR205 ARTICULATED SURGICAL LASER?

The FDA product code for MODEL: IR205 ARTICULATED SURGICAL LASER is GEX. This falls under the Gastroenterology category.

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

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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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