Product code MIB
- Device name
- Elastomer, Silicone Block
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3620
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241150 | MISTI Silicone Implant | Keosan Trading Co. | 2024-07-24 |
| K223051 | Pre-Formed Silicone Block | International Medical Devices, Inc. | 2023-02-03 |
| K222748 | ShiNeo Silicone Implant | Shineo Technology Co., Ltd. | 2022-12-23 |
| K200073 | AugMENTA Penile Implant | Augmenta, LLC | 2022-09-30 |
| K220760 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2022-05-13 |
| K193392 | BioSiCar Silicone Implant | Metalware Technology Corp. | 2020-07-20 |
| K181387 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2019-01-23 |
| K171851 | SOFTXIL | Bistool | 2018-03-16 |
| K162624 | Pre-Formed Penile Silicone Block | International Medical Devices, Inc. | 2017-02-01 |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Implantech Associates, Inc. | 2005-11-04 |
| K052505 | CALF IMPLANT, MODEL EC17-X | Implantech Associates, Inc. | 2005-11-04 |
| K042054 | SILIMED PECTORAL IMPLANT | Silimed, Inc. | 2005-02-23 |
| K042380 | SILICONE BLOCK | National Medical Devices, Inc. | 2004-10-25 |
| K040042 | MEDISIL SILICONE SHEETING | Medisil Corporation | 2004-04-01 |
| K030808 | HANSON MEDICAL CALF IMPLANT | Hanson Medical, Inc. | 2003-04-21 |
| K030809 | HANSON MEDICAL GLUTEAL IMPLANT | Hanson Medical, Inc. | 2003-04-21 |
| K022511 | AART CALF IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-08-26 |
| K022223 | AART SILICONE SHEETING | Aesthetic and Reconstructive Technologies, Inc. | 2002-08-08 |
| K021820 | AART SILICONE CARVING BLOCK | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-16 |
| K021839 | AART GLUTEAL IMPLANT | Aesthetic and Reconstructive Technologies, Inc. | 2002-07-16 |
| K983630 | SEARE BIOMEDICAL SILICONE RODS | Seare Biomedical Corp. | 1998-12-11 |
| K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | Spectrum Designs, Inc. | 1998-10-13 |
| K983041 | SEARE BIOMEDICAL SILICONE SHEETING | Seare Biomedical Corp. | 1998-09-30 |
| K982065 | STERILE SILICONE EXTERNAL WOUND COVER | Specialty Surgical Products, Inc. | 1998-08-12 |
| K981851 | SILIMED SILICONE CARVING BLOCK | Silimed, LLC | 1998-07-09 |
| K974653 | SILICONE ELASTOMER SHEETING | Specialty Surgical Products, Inc. | 1998-03-13 |
| K974654 | SILICONE BLOCKS | Specialty Surgical Products, Inc. | 1998-02-24 |
| K974482 | SILIMED GLUTEAL IMPLANT | Silimed, LLC | 1998-02-24 |
| K974480 | SILIMED CALF IMPLANT | Silimed, LLC | 1998-02-24 |
| K973730 | DURASIL I AND DURASIL II | Hanson Medical, Inc. | 1997-12-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M72460015NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72470005NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460160NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460150NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460140NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460130NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460120NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460115NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460110NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460107NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460060NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460050NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460040NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460030NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460020NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423700071 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460010NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460007NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72460005NS1 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423701401 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423701301 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423701201 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423701151 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423701101 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423701071 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423700401 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423700301 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423700201 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423700151 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |
| M72423700101 | AlliedSil™ Sheeting | IMPLANTECH ASSOCIATES, INC. | 2015-09-24 |