MIB · Elastomer, Silicone Block
Ear, Nose, Throat · 21 CFR 874.3620 · Class 2
Overview
| Product Code | MIB |
|---|---|
| Device Name | Elastomer, Silicone Block |
| Regulation | 21 CFR 874.3620 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241150 | MISTI Silicone Implant | Keosan Trading Co. | Jul 24, 2024 | SESE |
| K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | Feb 3, 2023 | SESE |
| K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | Dec 23, 2022 | SESE |
| K200073 | AugMENTA Penile Implant | Augmenta, LLC | Sep 30, 2022 | SESE |
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | May 13, 2022 | SESE |
| K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | Jul 20, 2020 | SESE |
| K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | Jan 23, 2019 | SESE |
| K171851 | SOFTXIL | Bistool | Mar 16, 2018 | SESE |
| K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | Feb 1, 2017 | SESE |
| K052505 | CALF IMPLANT, MODEL EC17-X | Implantech Associates, Inc. | Nov 4, 2005 | SESE |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Implantech Associates, Inc. | Nov 4, 2005 | SESE |
| K042054 | SILIMED PECTORAL IMPLANT | Silimed, Inc. | Feb 23, 2005 | SESE |
| K042380 | SILICONE BLOCK | National Medical Devices, Inc. | Oct 25, 2004 | SESE |
| K040042 | MEDISIL SILICONE SHEETING | Medisil Corporation | Apr 1, 2004 | SESE |
| K030809 | HANSON MEDICAL GLUTEAL IMPLANT | Hanson Medical, Inc. | Apr 21, 2003 | SESE |
| K030808 | HANSON MEDICAL CALF IMPLANT | Hanson Medical, Inc. | Apr 21, 2003 | SESE |
| K022511 | AART CALF IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Aug 26, 2002 | SESE |
| K022223 | AART SILICONE SHEETING | Aesthetic and Reconstructive Technologies, Inc. | Aug 8, 2002 | SESE |
| K021839 | AART GLUTEAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | Jul 16, 2002 | SESE |
| K021820 | AART SILICONE CARVING BLOCK | Aesthetic and Reconstructive Technologies, Inc. | Jul 16, 2002 | SESE |
Top Applicants
- Aesthetic and Reconstructive Technologies, Inc. — 4 clearances
- Hanson Medical, Inc. — 4 clearances
- International Medical Devices, Inc. — 4 clearances
- Allied Biomedical Corp. — 3 clearances
- Silimed, LLC — 3 clearances
