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FDA 510(k)

OMEGA ULTRASCAN

K-Number: K954911 · 1996-01-24

ApplicantGyne-Tech Instrument Corp.
Decision Date1996-01-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMEGA ULTRASCAN is the device name listed in this FDA 510(k) record. The listed applicant is Gyne-Tech Instrument Corp.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K954911. 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 OMEGA ULTRASCAN?

OMEGA ULTRASCAN is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Gyne-Tech Instrument Corp.. The 510(k) number is K954911.

When did OMEGA ULTRASCAN receive FDA 510(k) clearance?

OMEGA ULTRASCAN received FDA 510(k) clearance on 1996-01-24, under 510(k) number K954911.

Who is the listed applicant for OMEGA ULTRASCAN?

The FDA 510(k) record lists Gyne-Tech Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMEGA ULTRASCAN?

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

Related Clinical Trials

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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Other records listing Gyne-Tech Instrument Corp. 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.

K922878MODEL GT1ST CRYOSURGICAL INSTRUMENTK914367ELECTROSURGICAL GENERATOR MODEL ESU100/250/550

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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