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FDA 510(k)

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM

K-Number: K012628 · 2001-10-26

ApplicantGynecare Center
Decision Date2001-10-26
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gynecare Center. It received FDA 510(k) clearance on 2001-10-26 under 510(k) number K012628. 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 TENSION-FREE VAGINAL TAPE SYSTEM?

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Gynecare Center. The 510(k) number is K012628.

When did GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM receive FDA 510(k) clearance?

GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM received FDA 510(k) clearance on 2001-10-26, under 510(k) number K012628.

Who is the listed applicant for GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM?

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

What is the FDA product code for GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM?

The FDA product code for GYNECARE TENSION-FREE VAGINAL TAPE 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

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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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