Home / Device Classification / MIB

MIB — Elastomer, Silicone Block Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K241150keosan tradingMISTI Silicone ImplantJuly 24, 2024
K223051international medical devicesPre-Formed Silicone BlockFebruary 3, 2023
K222748shineo technology coShiNeo Silicone ImplantDecember 23, 2022
K200073augmentaAugMENTA Penile ImplantSeptember 30, 2022
K220760international medical devicesPre-Formed Penile Silicone BlockMay 13, 2022
K193392metalware technologyBioSiCar Silicone ImplantJuly 20, 2020
K181387international medical devicesPre-Formed Penile Silicone BlockJanuary 23, 2019
K171851bistoolSOFTXILMarch 16, 2018
K162624international medical devicesPre-Formed Penile Silicone BlockFebruary 1, 2017
K052505implantech associatesCALF IMPLANT, MODEL EC17-XNovember 4, 2005
K052504implantech associatesGLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XNovember 4, 2005
K042054silimedSILIMED PECTORAL IMPLANTFebruary 23, 2005
K042380national medical devicesSILICONE BLOCKOctober 25, 2004
K040042medisil corporationMEDISIL SILICONE SHEETINGApril 1, 2004
K030809hanson medicalHANSON MEDICAL GLUTEAL IMPLANTApril 21, 2003
K030808hanson medicalHANSON MEDICAL CALF IMPLANTApril 21, 2003
K022511aesthetic and reconstructive technologiesAART CALF IMPLANTAugust 26, 2002
K022223aesthetic and reconstructive technologiesAART SILICONE SHEETINGAugust 8, 2002
K021820aesthetic and reconstructive technologiesAART SILICONE CARVING BLOCKJuly 16, 2002
K021839aesthetic and reconstructive technologiesAART GLUTEAL IMPLANTJuly 16, 2002