Submission Details
| 510(k) Number | K241150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 2024 |
| Decision Date | July 24, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
MISTI Silicone Implant
Jul 2024
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K241150 is an FDA 510(k) clearance for the MISTI Silicone Implant, a Elastomer, Silicone Block (Class II — Special Controls, product code MIB), submitted by Keosan Trading Co. (Seoul, KR). The FDA issued a Cleared decision on July 24, 2024, 90 days after receiving the submission on April 25, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.
Device Classification
| Product Code | MIB — Elastomer, Silicone Block |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 874.3620 |
Manufacturer
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