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FDA 510(k)

FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201

K-Number: K955862 · 1996-03-01

ApplicantFull Spectrum, Inc.
Decision Date1996-03-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 is the device name listed in this FDA 510(k) record. The listed applicant is Full Spectrum, Inc.. It received FDA 510(k) clearance on 1996-03-01 under 510(k) number K955862. 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-OVERCLAD FIBER: MODEL 201?

FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 is a medical device that received FDA 510(k) clearance on 1996-03-01. The listed applicant is Full Spectrum, Inc.. The 510(k) number is K955862.

When did FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 receive FDA 510(k) clearance?

FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 received FDA 510(k) clearance on 1996-03-01, under 510(k) number K955862.

Who is the listed applicant for FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201?

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

What is the FDA product code for FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201?

The FDA product code for FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 201 is GEX. This falls under the Gastroenterology category.

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Other records listing Full Spectrum, 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.

K963991FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERSK963996(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 400

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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