FDA.reportPublic FDA data

Synaptix Plug B Type

Primary DI
08055713177046
Brand
Synaptix Plug B Type
Company
MEDICAL MICROINSTRUMENTS, INC.
Model
DWS-B1J000000W
Device description
An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SAQElectromechanical System For Open Microsurgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAQElectromechanical System For Open MicrosurgeryGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251510000Symani Surgical SystemMedical Microinstruments, Inc.2025-09-04SAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055713177046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055713177046080557131770468055713177046

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435958412
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055713170146"Symani Surgical Robot CMM Plug type ""B"""CMM-B0102025-04-21
08055713170504Symani Surgical Robot ConsoleCNS-1002025-04-21
08055713170511Symani Surgical Robot Console FlatCNS-0002025-04-21
08055713171082ScissorsINS-RfM32202026-03-06
08055713171099ForcepsINS-PbM12212026-03-06
08055713175011Symani Accessories Master ClipACC-2002025-04-21
08055713175028Symani Accessories Contoured Master ClipACC-2202025-04-21
08055713175035Symani Accessories Master HolderACC-3002025-04-21
08055713171020Symani NanoWrist Instruments Micro Needle HolderINS-AaT22212025-04-21
08055713171037Symani NanoWrist Instruments Micro Needle Holder Suture CutINS-AeT12212025-04-21
08055713171044Symani NanoWrist Instruments Micro DilatorINS-ObM12212025-04-21
08055713171051Symani NanoWrist Instruments SuperMicro Needle HolderINS-NaS22212025-04-21
08055713171068Symani NanoWrist Instruments SuperMicro DilatorINS-DbS12212025-04-21
08055713171075Symani NanoWrist Instruments SuperMicro Needle Holder Suture CutINS-NeS12212025-04-21
08055713175004Symani Accessories Instrument ConnectorACC-1012025-04-21
88055713175017Symani Accessories Master ClipACC-2002025-04-21
18055713175025Symani Accessories Contoured Master ClipACC-2202025-04-21
18055713175032Symani Accessories Master HolderACC-3002025-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055713171082ScissorsMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713171099ForcepsMEDICAL MICROINSTRUMENTS, INC.SAQ2026-03-06
08055713175011Symani Accessories Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175028Symani Accessories Contoured Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175035Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170146"Symani Surgical Robot CMM Plug type ""B"""MEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170504Symani Surgical Robot ConsoleMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713170511Symani Surgical Robot Console FlatMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171020Symani NanoWrist Instruments Micro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171037Symani NanoWrist Instruments Micro Needle Holder Suture CutMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171044Symani NanoWrist Instruments Micro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171051Symani NanoWrist Instruments SuperMicro Needle HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171068Symani NanoWrist Instruments SuperMicro DilatorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713171075Symani NanoWrist Instruments SuperMicro Needle Holder Suture CutMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
08055713175004Symani Accessories Instrument ConnectorMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
88055713175017Symani Accessories Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
18055713175025Symani Accessories Contoured Master ClipMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21
18055713175032Symani Accessories Master HolderMEDICAL MICROINSTRUMENTS, INC.SAQ2025-04-21