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FDA 510(k)

SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS

K-Number: K952733 · 1995-07-31

ApplicantMyriad Lase, Inc.
Decision Date1995-07-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS 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 1995-07-31 under 510(k) number K952733. 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 SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS?

SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Myriad Lase, Inc.. The 510(k) number is K952733.

When did SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS receive FDA 510(k) clearance?

SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS received FDA 510(k) clearance on 1995-07-31, under 510(k) number K952733.

Who is the listed applicant for SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS?

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 SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS?

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

Related Clinical Trials

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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)K952113TBN-TIPPED OPTICAL FIBERK920553MYRIADLASE SIDEFIRE-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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