Permacol Surgical Mesh

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Permacol

510(k) Number

K021056 ↗

FDA Product Code

FTM

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Permacol

  Class II

  FDA 510(k) K992556 Active Cleared 17 Feb 2000

• Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150

  Class III

  FDA 510(k) K050355 Active Cleared 9 Mar 2005

• Permacol Surgical Implant

  Class II

  FDA 510(k) K043366 Active Cleared 17 Dec 2004

• Zimmer Collagen Repair Patch

  Class II

  FDA 510(k) K053562 Active Cleared 23 Jun 2006

• Permacol Surgical Mesh

  Class II

  FDA 510(k) K013625 Active Cleared 17 Jan 2002

• What types of surgical procedures is Permacol designed to support, and how is it typically placed during surgery?

  Permacol is designed to reinforce soft tissue where structural weakness exists or to repair damaged or ruptured soft tissue membranes, providing durable support during surgical procedures. It is intended for use in general plastic surgery and can be placed via either laparoscopic or open surgical approaches. The mesh is specifically engineered to offer long-term reinforcement to tissues, making it suitable for procedures requiring stable, flexible reinforcement.

• Is Permacol reusable, or is it intended for single-use only? How is it supplied?

  Permacol is explicitly intended for single-use in surgical settings. It is supplied sterile, ensuring it is ready for immediate use without requiring additional sterilization procedures. This design minimizes the risk of contamination and ensures patient safety.

• What sizes are available for Permacol, and how do I determine the appropriate size for a patient?

  Permacol is available in various sizes, though the exact dimensions are not specified in the provided data. The selection of the appropriate size would depend on the specific anatomical requirements of the patient and the surgical procedure being performed. Consulting the manufacturer’s sizing guidelines or a surgical specialist is recommended to ensure proper fit and effectiveness.

• Can Permacol be used in MRI scans, or does it pose any risks during imaging?

  Permacol is explicitly noted as not MRI-compatible. This means it should not be used in patients who require MRI imaging, as the mesh could interfere with the scan or pose safety risks during the procedure. Always verify compatibility with imaging requirements before use.

• What is the regulatory pathway for Permacol, and how was its safety and effectiveness determined?

  Permacol underwent a 510(k) clearance process through the FDA, classified as a Class II medical device under 21 CFR 878.3300. The clearance was based on a determination of substantial equivalence to a predicate device, meaning its safety and effectiveness were compared to an already-approved surgical mesh. The device was reviewed by the Surgical Products (SU) Advisory Committee under the General, Plastic Surgery specialty.