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Pelvilace Transobturator Biourethral Support System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K042949

by C. R. Bard, Inc.

Identifiers

510(k) Number
K042949 FDA 510(k)
FDA Product Code
PAG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.3300 FDA 510(k)
Regulation Number
878.3300 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pelvilace Transobturator Biourethral Support System is a non-synthetic, urogynecologic surgical mesh. It is intended for use as a soft tissue patch to reinforce soft tissue membranes in patients with stress urinary incontinence.

This device is classified as a Class II medical device under regulation number 878.3300. It received FDA 510(k) clearance under K042949 and is manufactured by C. R. Bard, Inc.

Frequently asked questions

What is the primary clinical indication for the Pelvilace TO System?

The Pelvilace Transobturator Biourethral Support System is intended for use as a soft tissue patch. It is specifically designed to reinforce soft tissue membranes in patients who are suffering from stress urinary incontinence.

What type of material is used in this support system?

This device is categorized as a non-synthetic, urogynecologic surgical mesh. It is designed to function as a patch to provide structural reinforcement to soft tissue membranes.

What is the regulatory status of the Pelvilace TO System?

The Pelvilace Transobturator Biourethral Support System is a Class II medical device under regulation number 878.3300. It received FDA 510(k) clearance under submission number K042949, indicating it was found to be substantially equivalent to existing devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K042949 - PELVILACE TRANSOBTURATOR BIOURETHRAL SU... | FDA 510(k), Pelvilace Transobturator Biourethral Support System (pelvilace To ..., Pelvilace Transobturator Biourethral Support System (Pelvilace to ..., MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K042949 24 fields · synced Sep 25, 2026