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FDA 510(k)

HI-Q HAND INSTRUMENTS- UROLOGY

K-Number: K944201 · 1994-11-29

ApplicantOlympus America, Inc.
Decision Date1994-11-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HI-Q HAND INSTRUMENTS- UROLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1994-11-29 under 510(k) number K944201. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-Q HAND INSTRUMENTS- UROLOGY?

HI-Q HAND INSTRUMENTS- UROLOGY is a medical device that received FDA 510(k) clearance on 1994-11-29. The listed applicant is Olympus America, Inc.. The 510(k) number is K944201.

When did HI-Q HAND INSTRUMENTS- UROLOGY receive FDA 510(k) clearance?

HI-Q HAND INSTRUMENTS- UROLOGY received FDA 510(k) clearance on 1994-11-29, under 510(k) number K944201.

Who is the listed applicant for HI-Q HAND INSTRUMENTS- UROLOGY?

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

What is the FDA product code for HI-Q HAND INSTRUMENTS- UROLOGY?

The FDA product code for HI-Q HAND INSTRUMENTS- UROLOGY is GCJ.

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Related Devices (Code: GCJ)

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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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