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FDA 510(k)

GYNEGUIDE

K-Number: K894591 · 1989-10-10

ApplicantMarlo Surgical Technology
Decision Date1989-10-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GYNEGUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Marlo Surgical Technology. It received FDA 510(k) clearance on 1989-10-10 under 510(k) number K894591. 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 GYNEGUIDE?

GYNEGUIDE is a medical device that received FDA 510(k) clearance on 1989-10-10. The listed applicant is Marlo Surgical Technology. The 510(k) number is K894591.

When did GYNEGUIDE receive FDA 510(k) clearance?

GYNEGUIDE received FDA 510(k) clearance on 1989-10-10, under 510(k) number K894591.

Who is the listed applicant for GYNEGUIDE?

The FDA 510(k) record lists Marlo Surgical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYNEGUIDE?

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

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Other records listing Marlo Surgical Technology as applicant

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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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