Restorelle Polypropylene Mesh

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

510(k) Number

K092207 ↗

FDA Product Code

OTP

FDA applicant

Mpathy Medical Devices, Inc.

Device Class

Class III

Regulation

21 CFR Part 884.5980

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Modification to: Minimesh Polypropylene Mesh

  Class II

  FDA 510(k) K053361 Active Cleared 6 Feb 2006

• Minitape Urethral Sling

  Class II

  FDA 510(k) K091180 Active Cleared 14 Jul 2009

• Minimesh Polypropylene Mesh

  Class II

  FDA 510(k) K041632 Active Cleared 17 Nov 2004

• Minitape Extra Urethral Sling

  Class II

  FDA 510(k) K073647 Active Cleared 3 Mar 2008

• Omnisure Urethral Sling, Model OTK52

  Class II

  FDA 510(k) K092203 Active Cleared 12 Aug 2009

• Minitape Urethral Sling

  Class II

  FDA 510(k) K073646 Active Cleared 25 Feb 2008

• What types of pelvic organ prolapse procedures is the Restorelle Polypropylene Mesh intended for, and how is it placed during surgery?

  The Restorelle Polypropylene Mesh is designed specifically for transvaginal placement in reconstructive pelvic floor procedures. It is intended to provide support to weakened pelvic tissues affected by pelvic organ prolapse, helping to restore anatomical alignment and function. The mesh is inserted through the vaginal route by a healthcare professional during surgery, where it is positioned to reinforce the prolapsed organs.

• Is the Restorelle Polypropylene Mesh reusable, or is it meant for single-use only? How should it be stored to maintain sterility?

  The Restorelle Polypropylene Mesh is supplied as a single-use, sterile product, meaning it is intended for one surgical procedure only. To maintain sterility before use, it must be stored according to the manufacturer’s instructions, typically in a sealed, sterile packaging until the time of surgery. Proper storage conditions, such as avoiding contamination and extreme temperatures, are critical to preserving its integrity.

• What regulatory pathway does the Restorelle Polypropylene Mesh follow, and which advisory committee was involved in its review?

  The Restorelle Polypropylene Mesh follows the FDA’s 510(k) clearance pathway, specifically with a Special Substantial Equivalence (SESE) determination. Its review was conducted by the Obstetrics/Gynecology (OB) Advisory Committee, reflecting its classification as a Class III device under FDA regulations for urogynecologic surgical meshes.

• Are there different sizes or models of the Restorelle Polypropylene Mesh available, and how would a clinician determine the appropriate one for a patient?

  While the provided data does not specify exact sizes or models, the Restorelle Polypropylene Mesh is designed to accommodate various pelvic organ prolapse cases through transvaginal placement. Clinicians would typically select the appropriate size or configuration based on preoperative assessments, imaging, and surgical planning to ensure proper fit and support for the patient’s specific anatomical needs.