MIB
- Product code
- MIB
- Device name
- Elastomer, Silicone Block
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3620
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 45
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241150 | 2024-07-24 | Keosan Trading Co. | MISTI Silicone Implant |
Official FDA classification page: MIB
Classification and pathway per current FDA publications. Data from openFDA (CC0).