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FDA 510(k)

ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER)

K-Number: K953065 · 1995-09-27

ApplicantMicroquartz Medical, Inc.
Decision Date1995-09-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) is the device name listed in this FDA 510(k) record. The listed applicant is Microquartz Medical, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K953065. 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 ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER)?

ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Microquartz Medical, Inc.. The 510(k) number is K953065.

When did ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) receive FDA 510(k) clearance?

ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) received FDA 510(k) clearance on 1995-09-27, under 510(k) number K953065.

Who is the listed applicant for ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER)?

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

What is the FDA product code for ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER)?

The FDA product code for ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Microquartz Medical, 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.

K955861MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBERK954904MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBERK953174MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORYK952974QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER)K950710MICROQUARTZ MEDICAL SIDE-FIRING LASER 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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