FDA 510(k)

UNIPOLAR OPTICAL BIOPSY FORCEPS

K-Number: K983811 · 1998-12-24

Decision Date1998-12-24

Product CodeKGE

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

UNIPOLAR OPTICAL BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 1998-12-24 under 510(k) number K983811. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIPOLAR OPTICAL BIOPSY FORCEPS?

UNIPOLAR OPTICAL BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1998-12-24. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K983811.

When did UNIPOLAR OPTICAL BIOPSY FORCEPS receive FDA 510(k) clearance?

UNIPOLAR OPTICAL BIOPSY FORCEPS received FDA 510(k) clearance on 1998-12-24, under 510(k) number K983811.

Who is the listed applicant for UNIPOLAR OPTICAL BIOPSY FORCEPS?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIPOLAR OPTICAL BIOPSY FORCEPS?

The FDA product code for UNIPOLAR OPTICAL BIOPSY FORCEPS is KGE.

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Other records listing Olympus Winter & Ibe GmbH as applicant

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Related Devices (Code: KGE)

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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.