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FDA 510(k)

GYN-PROBE

K-Number: K895774 · 1990-01-03

ApplicantTrimedyne, Inc.
Decision Date1990-01-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GYN-PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1990-01-03 under 510(k) number K895774. 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 GYN-PROBE?

GYN-PROBE is a medical device that received FDA 510(k) clearance on 1990-01-03. The listed applicant is Trimedyne, Inc.. The 510(k) number is K895774.

When did GYN-PROBE receive FDA 510(k) clearance?

GYN-PROBE received FDA 510(k) clearance on 1990-01-03, under 510(k) number K895774.

Who is the listed applicant for GYN-PROBE?

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

What is the FDA product code for GYN-PROBE?

The FDA product code for GYN-PROBE is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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