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FDA 510(k)

DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS

K-Number: K926224 · 1993-07-22

ApplicantDiomedics, Inc.
Decision Date1993-07-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS is the device name listed in this FDA 510(k) record. The listed applicant is Diomedics, Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K926224. 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 DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS?

DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Diomedics, Inc.. The 510(k) number is K926224.

When did DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS receive FDA 510(k) clearance?

DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS received FDA 510(k) clearance on 1993-07-22, under 510(k) number K926224.

Who is the listed applicant for DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS?

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

What is the FDA product code for DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS?

The FDA product code for DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Diomedics, 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.

K073503VERSA LITEK982546PHASER-2000

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Official Source

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