MIB · Class II · 21 CFR 874.3620

FDA Product Code MIB: Elastomer, Silicone Block

Leading manufacturers include Aesthetic and Reconstructive Technologies, Inc., International Medical Devices, Inc. and Silimed, LLC.

45
Total
45
Cleared
113d
Avg days
1992
Since
Declining activity - 0 submissions in the last 2 years vs 3 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 Feb 01, 2017
Pre-Formed Penile Silicone Block
K162624
International Medical Devices, Inc.
General & Plastic Surgery · 134d
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 Feb 23, 2005
SILIMED PECTORAL IMPLANT
K042054
Silimed, Inc.
General & Plastic Surgery · 208d
Cleared Oct 25, 2004
SILICONE BLOCK
K042380
National Medical Devices, Inc.
General & Plastic Surgery · 54d
Cleared Aug 26, 2002
AART CALF IMPLANT
K022511
Aesthetic and Reconstructive Technologies, Inc.
General & Plastic Surgery · 27d
Cleared Aug 08, 2002
AART SILICONE SHEETING
K022223
Aesthetic and Reconstructive Technologies, Inc.
General & Plastic Surgery · 30d
Cleared Jul 16, 2002
AART SILICONE CARVING BLOCK
K021820
Aesthetic and Reconstructive Technologies, Inc.
General & Plastic Surgery · 42d
Cleared Jul 16, 2002
AART GLUTEAL IMPLANT
K021839
Aesthetic and Reconstructive Technologies, Inc.
General & Plastic Surgery · 42d
Cleared Dec 11, 1998
SEARE BIOMEDICAL SILICONE RODS
K983630
Seare Biomedical Corp.
General & Plastic Surgery · 57d
Cleared Oct 13, 1998
SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
K982688
Spectrum Designs, Inc.
General & Plastic Surgery · 71d
Cleared Sep 30, 1998
SEARE BIOMEDICAL SILICONE SHEETING
K983041
Seare Biomedical Corp.
General & Plastic Surgery · 30d
Cleared Aug 12, 1998
STERILE SILICONE EXTERNAL WOUND COVER
K982065
Specialty Surgical Products, Inc.
General & Plastic Surgery · 61d
Cleared Jul 09, 1998
SILIMED SILICONE CARVING BLOCK
K981851
Silimed, LLC
General & Plastic Surgery · 44d
Cleared Mar 13, 1998
SILICONE ELASTOMER SHEETING
K974653
Specialty Surgical Products, Inc.
General & Plastic Surgery · 88d
Cleared Feb 24, 1998
SILIMED CALF IMPLANT
K974480
Silimed, LLC
General & Plastic Surgery · 90d

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 3 in the prior period.