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FDA 510(k)

INNOVAQUARTZ GENERAL SHAPE LASER FIBER

K-Number: K994010 · 1999-12-17

ApplicantInnovaquartz
Decision Date1999-12-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INNOVAQUARTZ GENERAL SHAPE LASER FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Innovaquartz. It received FDA 510(k) clearance on 1999-12-17 under 510(k) number K994010. 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 INNOVAQUARTZ GENERAL SHAPE LASER FIBER?

INNOVAQUARTZ GENERAL SHAPE LASER FIBER is a medical device that received FDA 510(k) clearance on 1999-12-17. The listed applicant is Innovaquartz. The 510(k) number is K994010.

When did INNOVAQUARTZ GENERAL SHAPE LASER FIBER receive FDA 510(k) clearance?

INNOVAQUARTZ GENERAL SHAPE LASER FIBER received FDA 510(k) clearance on 1999-12-17, under 510(k) number K994010.

Who is the listed applicant for INNOVAQUARTZ GENERAL SHAPE LASER FIBER?

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

What is the FDA product code for INNOVAQUARTZ GENERAL SHAPE LASER FIBER?

The FDA product code for INNOVAQUARTZ GENERAL SHAPE LASER FIBER is GEX. This falls under the Gastroenterology category.

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Other records listing Innovaquartz 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.

K050108SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS

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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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