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Symani NanoWrist Instruments SuperMicro Needle Holder Suture Cut

Primary DI
08055713171075
Brand
Symani NanoWrist Instruments SuperMicro Needle Holder Suture Cut
Company
MEDICAL MICROINSTRUMENTS, INC.
Model
INS-NeS1221
Device description
A surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device.
Published
2025-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K250014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250014000Symani Surgical System (820-03830)Medical Microinstruments, Inc.2025-01-27SAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055713171075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055713171075080557131710758055713171075

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical needle holder, single-useA surgical device intended to be used in conjunction with a robotic surgical system, to grasp a suture needle when pushing/pulling the needle and attached suture through tissue for suturing during a robotic endoscopic (e.g., laparoscopic) procedure. It has a long slender shaft with a distal forceps-like gripping mechanism and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435958412
Device count
1
Serial number
true
Expiration 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
08055713177046Synaptix Plug B TypeDWS-B1J000000W2026-03-06
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
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
08055713177046Synaptix Plug B TypeMEDICAL 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
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