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Pelvic Floor Repair System

by Boston Scientific

510(k) K091131

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK091131 Date8 May 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OTP
Device class
Class III
Regulation
21 CFR Part 884.5980
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Surgical, Synthetic, Urogynecologic Mesh designed for transvaginal placement in the treatment of pelvic organ prolapse. Classified as a Class III device under FDA regulations, it is intended for reconstructive procedures to support pelvic floor anatomy and restore anatomical function in patients with prolapse-related symptoms.

The Pelvic Floor Repair System is supplied sterile for single-use and requires surgical implantation by a trained clinician. It is regulated under FDA 510(k) clearance (K091131) and adheres to the specifications for transvaginal mesh systems, including MRI safety considerations as outlined in regulation 884.5980. Storage and handling follow sterile surgical protocols, with no reusable components.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of pelvic organ prolapse symptoms does this device address, and how is it placed during surgery?

    The Pelvic Floor Repair System is designed to support pelvic floor anatomy and restore function in patients experiencing symptoms related to pelvic organ prolapse, such as pelvic pressure, discomfort, or visible bulging. It is specifically intended for transvaginal placement during reconstructive procedures to provide structural support where prolapse has occurred. The mesh is surgically implanted by a trained clinician to reinforce weakened pelvic tissues.

  • Is this device reusable, or is it meant for single-use only? How should it be stored?

    The Pelvic Floor Repair System is supplied sterile for single-use only, meaning it is intended to be used once and then discarded. Storage must follow sterile surgical protocols to maintain its integrity, as no reusable components are included in the system.

  • What safety considerations should clinicians be aware of when using this device, particularly regarding imaging?

    This device adheres to MRI safety guidelines outlined in FDA regulation 884.5980, meaning clinicians should verify compatibility with MRI systems before use. The mesh is designed for transvaginal placement and is intended for reconstructive procedures, so proper imaging protocols should account for the device’s placement to avoid interference or misinterpretation of scans.

  • How do I confirm the regulatory status of this device before purchasing or using it?

    This device holds FDA 510(k) clearance (K091131) and is classified as a Class III device under FDA regulations. It was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee and is intended for transvaginal mesh systems. To confirm its regulatory status, you can reference the FDA’s OpenFDA database using the device name, product code (OTP), or the clearance number provided.