Silimed Pectoral Implant

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

510(k) Number

K042054 ↗

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 Calf Implant

  Class II

  FDA 510(k) K974480 Active Cleared 24 Feb 1998

• Silimed Gluteal Implant

  Class II

  FDA 510(k) K974482 Active Cleared 24 Feb 1998

• 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 Silimed Pectoral Implant used for?

  The Silimed Pectoral Implant is designed specifically for pectoral augmentation or reconstruction procedures. Its cohesive silicone elastomer material is engineered to mimic natural tissue contours, providing a durable and form-stable alternative for soft tissue enhancement in the pectoral region. This makes it suitable for surgical use by qualified professionals seeking to restore or enhance breast tissue symmetry or volume.

• How is the Silimed Pectoral Implant supplied, and what are its sterility and usage requirements?

  The Silimed Pectoral Implant is supplied as a single-use device, ensuring sterility and compliance with sterile medical device protocols. It is intended exclusively for surgical implantation by qualified medical professionals in sterile conditions. This design minimizes contamination risks and adheres to regulatory standards for Class II devices, ensuring safe and controlled use in clinical settings.

• What registration numbers or models are available for the Silimed Pectoral Implant?

  The Silimed Pectoral Implant is available under multiple registration numbers, including 3010606546, 1018470, 2182979, 3014664527, and others. These unique identifiers correspond to different variants or sizes within the product line, allowing clinicians to select the appropriate implant based on patient-specific anatomical requirements. The full list of registration numbers can be referenced in the device’s regulatory documentation.

• How should the Silimed Pectoral Implant be stored?

  The Silimed Pectoral Implant must be stored according to sterile medical device protocols to maintain its integrity and sterility. Proper storage conditions include keeping the device in its original, unopened packaging, away from direct sunlight, extreme temperatures, and contaminants. Adherence to these guidelines ensures the implant remains safe for surgical use and complies with regulatory standards for Class II devices.

• What regulatory pathway does the Silimed Pectoral Implant follow?

  The Silimed Pectoral Implant follows the FDA’s Traditional review pathway under 510(k) clearance (K042054), categorized under product code MIB for Ear, Nose, and Throat procedures. This classification reflects its use in soft tissue augmentation and reconstruction, with a decision description of 'Substantially Equivalent' to predicate devices. The implant is governed by regulatory standards for Class II devices under 874.3620, ensuring compliance with safety and performance requirements.