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FDA 510(k)

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH

K-Number: K972426 · 1997-09-23

ApplicantImagyn Medical, Inc.
Decision Date1997-09-23
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Imagyn Medical, Inc.. It received FDA 510(k) clearance on 1997-09-23 under 510(k) number K972426. 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 MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH?

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH is a medical device that received FDA 510(k) clearance on 1997-09-23. The listed applicant is Imagyn Medical, Inc.. The 510(k) number is K972426.

When did MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH receive FDA 510(k) clearance?

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH received FDA 510(k) clearance on 1997-09-23, under 510(k) number K972426.

Who is the listed applicant for MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH?

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

What is the FDA product code for MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH?

The FDA product code for MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH is HIH.

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Other records listing Imagyn Medical, Inc. as applicant

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Related Devices (Code: HIH)

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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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