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FDA 510(k)

VERSA-VU

K-Number: K951898 · 1995-12-11

ApplicantCooperSurgical, Inc.
Decision Date1995-12-11
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VERSA-VU is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 1995-12-11 under 510(k) number K951898. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSA-VU?

VERSA-VU is a medical device that received FDA 510(k) clearance on 1995-12-11. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K951898.

When did VERSA-VU receive FDA 510(k) clearance?

VERSA-VU received FDA 510(k) clearance on 1995-12-11, under 510(k) number K951898.

Who is the listed applicant for VERSA-VU?

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

What is the FDA product code for VERSA-VU?

The FDA product code for VERSA-VU is HIB.

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Other records listing CooperSurgical, Inc. as applicant

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Related Devices (Code: HIB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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