BioSiCar Silicone Implant

FDA 510(k) K193392 · Metalware Technology Corp.

Substantially Equivalent

510(k) numberK193392

Submission

Device name
BioSiCar Silicone Implant
Applicant
Metalware Technology Corp.
New Taipei City, TW
Received
December 6, 2019
Decision date
July 20, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MIB – Elastomer, Silicone Block
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3620
Specialty
Ear, Nose, Throat
Implant
Yes

Other 510(k)s with product code MIB

510(k)DeviceApplicantDecision
K241150MISTI Silicone ImplantMIB · Traditional Keosan Trading Co.07/24/2024SE
K223051Pre-Formed Silicone BlockMIB · Traditional International Medical Devices, Inc.02/03/2023SE
K222748ShiNeo Silicone ImplantMIB · Traditional Shineo Technology Co., Ltd.12/23/2022SE
K200073AugMENTA Penile ImplantMIB · Traditional Augmenta, LLC09/30/2022SE
K220760Pre-Formed Penile Silicone BlockMIB · Traditional International Medical Devices, Inc.05/13/2022SE
K181387Pre-Formed Penile Silicone BlockMIB · Traditional International Medical Devices, Inc.01/23/2019SE
K171851SoftxilMIB · Traditional Bistool03/16/2018SE
K162624Pre-Formed Penile Silicone BlockMIB · Traditional International Medical Devices, Inc.02/01/2017SE
K052505Calf Implant, Model EC17-XMIB · Traditional Implantech Associates, Inc.11/04/2005SE
K052504Gluteal Implant, Models RND 5-X, TRD 6-XMIB · Traditional Implantech Associates, Inc.11/04/2005SE

Questions and answers

When was BioSiCar Silicone Implant cleared by the FDA?

BioSiCar Silicone Implant (K193392) received a 510(k) decision of Substantially Equivalent on July 20, 2020, 227 days after the submission was received.

What is the product code of K193392?

The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.