Porex Ear Prosthesis

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

Full name

Porex(Tm) Ear Prosthesis

510(k) Number

K863939 ↗

FDA Product Code

FZD

Device Class

Class II

Regulation

21 CFR Part 878.3590

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Porex(Tm) Malar Implant

  Not classified

  FDA 510(k) K870182 Active Cleared 24 Feb 1987

• Porex(Tm) Extra-Ocular Orbital Implant

  Class II

  FDA 510(k) K863946 Active Cleared 27 Feb 1987

• Porex(Tm) Tissue Expander

  Unclassified

  FDA 510(k) K870154 Active Cleared 24 Feb 1987

• Tls Bulb Drainage System

  Class I

  FDA 510(k) K833586 Active Cleared 30 Jan 1984

• Porex Nerve Locator

  Class II

  FDA 510(k) K872791 Active Cleared 20 Oct 1987

• Porex(Tm) Nose Prosthesis

  Class II

  FDA 510(k) K863942 Active Cleared 24 Oct 1986

See all devices from Porex Medical →

• What is the Porex Ear Prosthesis used for?

  The Porex Ear Prosthesis is designed for internal use to replace or reconstruct a missing or malformed ear structure. It serves as a medical device for patients who require ear reconstruction due to congenital conditions, trauma, or surgical removal.

• Is the Porex Ear Prosthesis single-use or reusable?

  The Porex Ear Prosthesis is supplied as either a single-use or reusable product, though the specific sterility status is not detailed in the provided information. Users should consult the product instructions for proper handling and disposal guidelines.

• What sizes and models are available for the Porex Ear Prosthesis?

  The Porex Ear Prosthesis is available in various sizes and models to accommodate different patient needs, though specific dimensions are not provided in the device data. The appropriate size and model should be selected based on the patient's individual anatomical requirements.

• What is the regulatory status of the Porex Ear Prosthesis?

  The Porex Ear Prosthesis has FDA 510(k) clearance with product code FZD and is classified under regulation number 878.3590. It was determined to be substantially equivalent to predicate devices through the traditional clearance process.