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FDA 510(k)

GYNECARE PROLENE FASTENER SYSTEM

K-Number: K042603 · 2004-12-22

ApplicantETHICON, Inc.
Decision Date2004-12-22
Product CodePBQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GYNECARE PROLENE FASTENER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2004-12-22 under 510(k) number K042603. The device is classified under product code PBQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNECARE PROLENE FASTENER SYSTEM?

GYNECARE PROLENE FASTENER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-22. The listed applicant is ETHICON, Inc.. The 510(k) number is K042603.

When did GYNECARE PROLENE FASTENER SYSTEM receive FDA 510(k) clearance?

GYNECARE PROLENE FASTENER SYSTEM received FDA 510(k) clearance on 2004-12-22, under 510(k) number K042603.

Who is the listed applicant for GYNECARE PROLENE FASTENER SYSTEM?

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

What is the FDA product code for GYNECARE PROLENE FASTENER SYSTEM?

The FDA product code for GYNECARE PROLENE FASTENER SYSTEM is PBQ.

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Related Devices (Code: PBQ)

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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