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FDA 510(k)

IOGYN ENDOSCOPE

K-Number: K123330 · 2013-03-19

ApplicantIogyn, Inc.
Decision Date2013-03-19
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IOGYN ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Iogyn, Inc.. It received FDA 510(k) clearance on 2013-03-19 under 510(k) number K123330. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IOGYN ENDOSCOPE?

IOGYN ENDOSCOPE is a medical device that received FDA 510(k) clearance on 2013-03-19. The listed applicant is Iogyn, Inc.. The 510(k) number is K123330.

When did IOGYN ENDOSCOPE receive FDA 510(k) clearance?

IOGYN ENDOSCOPE received FDA 510(k) clearance on 2013-03-19, under 510(k) number K123330.

Who is the listed applicant for IOGYN ENDOSCOPE?

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

What is the FDA product code for IOGYN ENDOSCOPE?

The FDA product code for IOGYN ENDOSCOPE is HIH.

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Related Devices (Code: HIH)

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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