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FDA 510(k)

FULL SPECTRUM ULE FIBER, MODEL FF101

K-Number: K920596 · 1994-09-06

ApplicantGerald J. Shirk, M.D.
Decision Date1994-09-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FULL SPECTRUM ULE FIBER, MODEL FF101 is the device name listed in this FDA 510(k) record. The listed applicant is Gerald J. Shirk, M.D.. It received FDA 510(k) clearance on 1994-09-06 under 510(k) number K920596. 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 FULL SPECTRUM ULE FIBER, MODEL FF101?

FULL SPECTRUM ULE FIBER, MODEL FF101 is a medical device that received FDA 510(k) clearance on 1994-09-06. The listed applicant is Gerald J. Shirk, M.D.. The 510(k) number is K920596.

When did FULL SPECTRUM ULE FIBER, MODEL FF101 receive FDA 510(k) clearance?

FULL SPECTRUM ULE FIBER, MODEL FF101 received FDA 510(k) clearance on 1994-09-06, under 510(k) number K920596.

Who is the listed applicant for FULL SPECTRUM ULE FIBER, MODEL FF101?

The FDA 510(k) record lists Gerald J. Shirk, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FULL SPECTRUM ULE FIBER, MODEL FF101?

The FDA product code for FULL SPECTRUM ULE FIBER, MODEL FF101 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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