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FDA 510(k)

HI-Q HAND INSTRUMENTS, OB/GYN USE

K-Number: K944200 · 1995-09-15

ApplicantOlympus America, Inc.
Decision Date1995-09-15
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HI-Q HAND INSTRUMENTS, OB/GYN USE 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 1995-09-15 under 510(k) number K944200. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-Q HAND INSTRUMENTS, OB/GYN USE?

HI-Q HAND INSTRUMENTS, OB/GYN USE is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Olympus America, Inc.. The 510(k) number is K944200.

When did HI-Q HAND INSTRUMENTS, OB/GYN USE receive FDA 510(k) clearance?

HI-Q HAND INSTRUMENTS, OB/GYN USE received FDA 510(k) clearance on 1995-09-15, under 510(k) number K944200.

Who is the listed applicant for HI-Q HAND INSTRUMENTS, OB/GYN USE?

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, OB/GYN USE?

The FDA product code for HI-Q HAND INSTRUMENTS, OB/GYN USE is HET.

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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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