Seare Biomedical Silicone Block

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K983043 ↗

FDA Product Code

MIC

Device Class

Class II

Regulation

21 CFR Part 874.3620

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Seare Biomedical Silicone Tissue Expander

  Unclassified

  FDA 510(k) K983792 Active Cleared 11 Dec 1998

• Seare Biomedical Silicone Sheeting

  Class II

  FDA 510(k) K983041 Active Cleared 30 Sep 1998

• Seare Biomedical Nasal Implants

  Class II

  FDA 510(k) K982753 Active Cleared 30 Sep 1998

• Seare Biomedical Malar Implants

  Class II

  FDA 510(k) K982763 Active Cleared 30 Sep 1998

• Seare Biomedical Chin Implants

  Class II

  FDA 510(k) K982752 Active Cleared 30 Sep 1998

• Seare Biomedical Pectoralis Implant

  Class II

  FDA 510(k) K982762 Active Cleared 30 Sep 1998

See all devices from Seare Biomedical Corp. →

• What is the Seare Biomedical Silicone Block used for?

  The Seare Biomedical Silicone Block is designed for reconstructive procedures, specifically within the pectoralis muscle. Surgeons use it to carve custom silicone implants tailored to address soft tissue deformities, particularly in ear, nose, and throat (ENT) applications. Its adaptability allows for precise contouring to meet individual patient needs.

• Is the silicone block reusable or single-use?

  The Seare Biomedical Silicone Block is supplied as a reusable device. It is intended for surgical carving by the operating surgeon to create custom implants. However, it is not pre-sterilized and must be sterilized by the user prior to use, as it is not supplied in a sterile state.

• How should the silicone block be stored?

  While the device data does not specify storage conditions, reusable silicone implants like this typically require clean, dry storage in a sealed container to prevent contamination. The block should be stored in a way that maintains its integrity until sterilization for use. Always follow manufacturer guidelines for optimal storage and handling.

• Does the silicone block come in different sizes or models?

  The Seare Biomedical Silicone Block is designed to be carved by the surgeon to fit individual patient needs, meaning it is not pre-sized or pre-shaped. The block’s adaptability allows for customization during surgery, ensuring tailored implants for reconstructive procedures.

• What regulatory pathway was used for clearance of this device?

  The Seare Biomedical Silicone Block was cleared through the Traditional 510(k) pathway under the FDA’s Class 2 General & Plastic Surgery category (regulation number 874.3620). It was reviewed by the Surgical and Urological Devices Subcommittee (SU) and the Ear, Nose, and Throat (ENT) advisory committee, with a decision of Substantially Equivalent (SESE).