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FDA 510(k)

MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER

K-Number: K920553 · 1992-03-26

ApplicantMyriad Lase, Inc.
Decision Date1992-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Myriad Lase, Inc.. It received FDA 510(k) clearance on 1992-03-26 under 510(k) number K920553. 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 MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER?

MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER is a medical device that received FDA 510(k) clearance on 1992-03-26. The listed applicant is Myriad Lase, Inc.. The 510(k) number is K920553.

When did MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER receive FDA 510(k) clearance?

MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER received FDA 510(k) clearance on 1992-03-26, under 510(k) number K920553.

Who is the listed applicant for MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER?

The FDA 510(k) record lists Myriad Lase, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER?

The FDA product code for MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER is GEX. This falls under the Gastroenterology category.

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Other records listing Myriad Lase, 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.

K965180STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000)K952733SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERSK952113TBN-TIPPED OPTICAL FIBER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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