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FDA 510(k)

GYNECARE TVT EXACT CONTINENCE SYSTEM

K-Number: K100485 · 2010-03-16

ApplicantETHICON, Inc.
Decision Date2010-03-16
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GYNECARE TVT EXACT CONTINENCE 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 2010-03-16 under 510(k) number K100485. 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 EXACT CONTINENCE SYSTEM?

GYNECARE TVT EXACT CONTINENCE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-16. The listed applicant is ETHICON, Inc.. The 510(k) number is K100485.

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

GYNECARE TVT EXACT CONTINENCE SYSTEM received FDA 510(k) clearance on 2010-03-16, under 510(k) number K100485.

Who is the listed applicant for GYNECARE TVT EXACT CONTINENCE 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 EXACT CONTINENCE SYSTEM?

The FDA product code for GYNECARE TVT EXACT CONTINENCE SYSTEM is OTN.

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Related Devices (Code: OTN)

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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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