MIB — Elastomer, Silicone Block Class II
FDA product code MIB covers "Elastomer, Silicone Block", a Class II medical device regulated under 21 CFR 874.3620. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MIB
- Device Class
- Class II
- Regulation Number
- 874.3620
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K241150 | keosan trading | MISTI Silicone Implant | July 24, 2024 |
| K223051 | international medical devices | Pre-Formed Silicone Block | February 3, 2023 |
| K222748 | shineo technology co | ShiNeo Silicone Implant | December 23, 2022 |
| K200073 | augmenta | AugMENTA Penile Implant | September 30, 2022 |
| K220760 | international medical devices | Pre-Formed Penile Silicone Block | May 13, 2022 |
| K193392 | metalware technology | BioSiCar Silicone Implant | July 20, 2020 |
| K181387 | international medical devices | Pre-Formed Penile Silicone Block | January 23, 2019 |
| K171851 | bistool | SOFTXIL | March 16, 2018 |
| K162624 | international medical devices | Pre-Formed Penile Silicone Block | February 1, 2017 |
| K052505 | implantech associates | CALF IMPLANT, MODEL EC17-X | November 4, 2005 |
| K052504 | implantech associates | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | November 4, 2005 |
| K042054 | silimed | SILIMED PECTORAL IMPLANT | February 23, 2005 |
| K042380 | national medical devices | SILICONE BLOCK | October 25, 2004 |
| K040042 | medisil corporation | MEDISIL SILICONE SHEETING | April 1, 2004 |
| K030808 | hanson medical | HANSON MEDICAL CALF IMPLANT | April 21, 2003 |
| K030809 | hanson medical | HANSON MEDICAL GLUTEAL IMPLANT | April 21, 2003 |
| K022511 | aesthetic and reconstructive technologies | AART CALF IMPLANT | August 26, 2002 |
| K022223 | aesthetic and reconstructive technologies | AART SILICONE SHEETING | August 8, 2002 |
| K021839 | aesthetic and reconstructive technologies | AART GLUTEAL IMPLANT | July 16, 2002 |
| K021820 | aesthetic and reconstructive technologies | AART SILICONE CARVING BLOCK | July 16, 2002 |