Permacol Surgical Mesh

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

Full name

Permacol

510(k) Number

K013625 ↗

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) K021056 Active Cleared 31 Oct 2002

• What types of surgical procedures is Permacol Surgical Mesh intended for, and how is it typically applied?

  Permacol Surgical Mesh is designed to reinforce soft tissue where structural weakness exists, as well as to repair damaged or ruptured soft tissue membranes. It serves as a soft tissue patch and is intended for use in general plastic surgery applications. The mesh can be applied via either laparoscopic or open surgical approaches, depending on the clinical scenario and surgeon preference.

• Is Permacol Surgical Mesh single-use or reusable, and what is its sterility status?

  Permacol Surgical Mesh is supplied sterile and is intended for single-use only. The device is not designed for reuse, as its sterile barrier would be compromised after a single surgical application, posing potential risks to patient safety.

• How is Permacol Surgical Mesh regulated, and what does its classification mean for clinicians?

  Permacol Surgical Mesh is regulated under the FDA’s 510(k) clearance process (K013625) and is classified as a Class II medical device. This classification indicates that it poses moderate risk and requires specific manufacturing controls to ensure safety and effectiveness. The device is authorized for general plastic surgery applications, as confirmed by its filing under the product code FTM and advisory committee designation for General, Plastic Surgery.

• What should clinicians consider regarding storage and handling of Permacol Surgical Mesh?

  Since Permacol Surgical Mesh is supplied sterile, it must be stored in its original packaging until ready for use to maintain sterility. The packaging should be kept dry, protected from direct sunlight, and within the recommended temperature range (typically room temperature) to preserve the integrity of the device. Always follow manufacturer guidelines for unpacking and preparing the mesh for surgery to avoid contamination.