FDA.reportPublic FDA data

510(k) K193392

Device
BioSiCar Silicone Implant
Applicant
Metalware Technology Corp.
510(k) number
K193392
Product code
MIB
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-20
Date received
2019-12-06
Regulation
874.3620
Classification name
Elastomer, Silicone Block
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Megan Chang
Address
10f, # 117, Minquan Rd., Xindian Dist. New Taipei City TW 231 231

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MIB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241150MISTI Silicone ImplantKeosan Trading Co.2024-07-24
K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.2023-02-03
K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.2022-12-23
K200073AugMENTA Penile ImplantAugmenta, LLC2022-09-30
K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.2022-05-13
K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.2019-01-23
K171851SOFTXILBistool2018-03-16
K162624Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.2017-02-01
K052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XImplantech Associates, Inc.2005-11-04
K052505CALF IMPLANT, MODEL EC17-XImplantech Associates, Inc.2005-11-04
K042054SILIMED PECTORAL IMPLANTSilimed, Inc.2005-02-23
K042380SILICONE BLOCKNational Medical Devices, Inc.2004-10-25
K040042MEDISIL SILICONE SHEETINGMedisil Corporation2004-04-01
K030808HANSON MEDICAL CALF IMPLANTHanson Medical, Inc.2003-04-21
K030809HANSON MEDICAL GLUTEAL IMPLANTHanson Medical, Inc.2003-04-21