MIB · Class II · 21 CFR 874.3620

FDA Product Code MIB: Elastomer, Silicone Block

Leading manufacturers include International Medical Devices, Inc., Implantech Associates, Inc. and Bistool.

45
Total
45
Cleared
113d
Avg days
1992
Since
Declining activity - 0 submissions in the last 2 years vs 4 in the prior period

FDA 510(k) Cleared Elastomer, Silicone Block Devices (Product Code MIB)

45 devices
1–24 of 45
Cleared Jul 24, 2024
MISTI Silicone Implant
K241150
Keosan Trading Co.
General & Plastic Surgery · 90d
Cleared Feb 03, 2023
Pre-Formed Silicone Block
K223051
International Medical Devices, Inc.
General & Plastic Surgery · 127d
Cleared Dec 23, 2022
ShiNeo Silicone Implant
K222748
Shineo Technology Co., Ltd.
General & Plastic Surgery · 102d
Cleared Sep 30, 2022
AugMENTA Penile Implant
K200073
Augmenta, LLC
General & Plastic Surgery · 990d
Cleared May 13, 2022
Pre-Formed Penile Silicone Block
K220760
International Medical Devices, Inc.
General & Plastic Surgery · 59d
Cleared Jul 20, 2020
BioSiCar Silicone Implant
K193392
Metalware Technology Corp.
General & Plastic Surgery · 227d
Cleared Jan 23, 2019
Pre-Formed Penile Silicone Block
K181387
International Medical Devices, Inc.
General & Plastic Surgery · 243d
Cleared Mar 16, 2018
SOFTXIL
K171851
Bistool
General & Plastic Surgery · 268d
Cleared Nov 04, 2005
GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
K052504
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared Nov 04, 2005
CALF IMPLANT, MODEL EC17-X
K052505
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared Apr 21, 1992
ZARA SILICONE BLOCK
K913882
Byron Medical
General & Plastic Surgery · 236d

About Product Code MIB - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code MIB since 1992, with 45 receiving FDA clearance (average review time: 113 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 4 in the prior period.