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FDA 510(k)

GYNECARE TVT OBTURATOR SYSTEM

K-Number: K033568 · 2003-12-08

ApplicantETHICON, Inc.
Decision Date2003-12-08
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GYNECARE TVT OBTURATOR 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 2003-12-08 under 510(k) number K033568. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYNECARE TVT OBTURATOR SYSTEM?

GYNECARE TVT OBTURATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2003-12-08. The listed applicant is ETHICON, Inc.. The 510(k) number is K033568.

When did GYNECARE TVT OBTURATOR SYSTEM receive FDA 510(k) clearance?

GYNECARE TVT OBTURATOR SYSTEM received FDA 510(k) clearance on 2003-12-08, under 510(k) number K033568.

Who is the listed applicant for GYNECARE TVT OBTURATOR 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 TVT OBTURATOR SYSTEM?

The FDA product code for GYNECARE TVT OBTURATOR SYSTEM is OTN.

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Related Devices (Code: OTN)

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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