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FDA 510(k)

VERSAPOINT RESECTOSCOPIC SYSTEM

K-Number: K040302 · 2004-03-09

ApplicantGynecare, A Div. of Ethicon, Inc.
Decision Date2004-03-09
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VERSAPOINT RESECTOSCOPIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare, A Div. of Ethicon, Inc.. It received FDA 510(k) clearance on 2004-03-09 under 510(k) number K040302. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSAPOINT RESECTOSCOPIC SYSTEM?

VERSAPOINT RESECTOSCOPIC SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-09. The listed applicant is Gynecare, A Div. of Ethicon, Inc.. The 510(k) number is K040302.

When did VERSAPOINT RESECTOSCOPIC SYSTEM receive FDA 510(k) clearance?

VERSAPOINT RESECTOSCOPIC SYSTEM received FDA 510(k) clearance on 2004-03-09, under 510(k) number K040302.

Who is the listed applicant for VERSAPOINT RESECTOSCOPIC SYSTEM?

The FDA 510(k) record lists Gynecare, A Div. of Ethicon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSAPOINT RESECTOSCOPIC SYSTEM?

The FDA product code for VERSAPOINT RESECTOSCOPIC SYSTEM is HIH.

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Other records listing Gynecare, A Div. of Ethicon, Inc. as applicant

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Related Devices (Code: HIH)

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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.

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