Silimed Calf Implant

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

510(k) Number

K974480 ↗

FDA Product Code

MIB

Device Class

Class II

Regulation

21 CFR Part 874.3620

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Silimed Vaginal Stent

  Class II

  FDA 510(k) K974479 Active Cleared 5 Aug 1998

• Silimed Nasal Retainer

  Class I

  FDA 510(k) K980221 Active Cleared 2 Apr 1998

• Silimed Gluteal Implant

  Class II

  FDA 510(k) K974482 Active Cleared 24 Feb 1998

• Silimed Pectoral Implant

  Class II

  FDA 510(k) K042054 Active Cleared 23 Feb 2005

• Silimed Nasal L Shaped Implant

  Class II

  FDA 510(k) K981833 Active Cleared 26 Jun 1998

• Silimed Silicone Carving Block

  Class II

  FDA 510(k) K981851 Active Cleared 9 Jul 1998

See all devices from Silimed, LLC →

• What is the primary purpose of the Silimed Calf Implant?

  This device is a silicone block intended for use in reconstructive, corrective, or aesthetic surgical procedures. It functions as a carving block, allowing surgeons to customize the implant shape to effectively simulate tissues within the calf region.

• What is the regulatory status of this device?

  The Silimed Calf Implant has received FDA 510(k) clearance under the submission number K974480. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

• How is the Silimed Calf Implant classified?

  The device is classified as a silicone block elastomer, identified by product code MIB and regulation number 874.3620. It is intended for surgical applications where a customizable silicone material is required for tissue simulation.