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FDA 510(k)

LAPAROSCOPE AND ACCESSORIES FOR OB/GYN

K-Number: K950232 · 1995-03-16

ApplicantOlympus America, Inc.
Decision Date1995-03-16
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPE AND ACCESSORIES FOR OB/GYN 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 1995-03-16 under 510(k) number K950232. 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 LAPAROSCOPE AND ACCESSORIES FOR OB/GYN?

LAPAROSCOPE AND ACCESSORIES FOR OB/GYN is a medical device that received FDA 510(k) clearance on 1995-03-16. The listed applicant is Olympus America, Inc.. The 510(k) number is K950232.

When did LAPAROSCOPE AND ACCESSORIES FOR OB/GYN receive FDA 510(k) clearance?

LAPAROSCOPE AND ACCESSORIES FOR OB/GYN received FDA 510(k) clearance on 1995-03-16, under 510(k) number K950232.

Who is the listed applicant for LAPAROSCOPE AND ACCESSORIES FOR OB/GYN?

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 LAPAROSCOPE AND ACCESSORIES FOR OB/GYN?

The FDA product code for LAPAROSCOPE AND ACCESSORIES FOR OB/GYN 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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