FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
MISTI Silicone Implant
K Number: K241150
·
Decision Jul 24, 2024
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
44
Applicant Total
2
Review Days
90
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Basic Information
- Device Name
- MISTI Silicone Implant
- K Number
- K241150
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3620
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keosan Trading Co.
- Date Received
- April 25, 2024
- Decision Date
- July 24, 2024
- Product Code
- MIB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MIB | Elastomer, Silicone Block | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MIB), ordered by most recent decision date.
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BioSiCar Silicone Implant
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FDA Class 2
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Pre-Formed Penile Silicone Block
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Keosan Trading Co.
| K Number | Device Name | ||
|---|---|---|---|
| K232593 | FITme Customized Silicone Implant | Nov 22, 2023 | Substantially Equivalent |