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FDA 510(k)

OPTIFIBER

K-Number: K914423 · 1991-12-02

ApplicantMinimal Invasive Therapy and Diagnostics, Inc.
Decision Date1991-12-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTIFIBER is the device name listed in this FDA 510(k) record. The listed applicant is Minimal Invasive Therapy and Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-12-02 under 510(k) number K914423. 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 OPTIFIBER?

OPTIFIBER is a medical device that received FDA 510(k) clearance on 1991-12-02. The listed applicant is Minimal Invasive Therapy and Diagnostics, Inc.. The 510(k) number is K914423.

When did OPTIFIBER receive FDA 510(k) clearance?

OPTIFIBER received FDA 510(k) clearance on 1991-12-02, under 510(k) number K914423.

Who is the listed applicant for OPTIFIBER?

The FDA 510(k) record lists Minimal Invasive Therapy and Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIFIBER?

The FDA product code for OPTIFIBER is GEX. This falls under the Gastroenterology category.

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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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