Class Class II
MISTI Silicone Implant (K241150)
Description
MISTI Silicone Implant by Keosan Trading Co., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241150
Clearance Date2024-07-24
Clearance TypeTraditional
Product CodeMIB
Regulation Number874.3620
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241150
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MISTI Silicone Implant (K241150) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171851 | SOFTXIL | Bistool | 2018 |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Implantech Associates, Inc. | 2005 |
| K052505 | CALF IMPLANT, MODEL EC17-X | Implantech Associates, Inc. | 2005 |
Trace the full predicate network for K241150
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.