Symani Surgical System
Medical Microinstruments, Inc.
MEDICAL MICROINSTRUMENTS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3030831003 | 3030831003 | MEDICAL MICROINSTRUMENTS, INC. | 1 | N | 2026-01-01 | Via Egidio Giannessi 54 Pisa IT 56121 |
| 3033523743 | 3033523743 | MEDICAL MICROINSTRUMENTS, INC. | 1 | N | 2026-01-01 | Via Spagna 11 Cascina Pisa IT 56021 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 327649 | 2013322486 | K252287 | Symani Surgical System | SAQ | 2025-11-10 |
| 327649 | 1037435370 | K251510 | Symani Surgical System | SAQ | 2025-09-04 |
| 332034 | 1037435370 | K251510 | Symani Surgical System | SAQ | 2025-09-04 |
| 327649 | 2031075104 | K250014 | Symani Surgical System (820-03830) | SAQ | 2025-01-27 |
| 327649 | 2011609122 | K242368 | Symani Surgical System | SAQ | 2025-02-07 |
| 332034 | 2011609122 | K242368 | Symani Surgical System | SAQ | 2025-02-07 |
| 327649 | 1892585676 | DEN230032 | Symani Surgical System | SAQ | 2024-04-05 |
| 332034 | 1892585676 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| SAQ | 7 | 2025-11-10 |
PMN#
Symani Surgical System
Medical Microinstruments, Inc.
Symani Surgical System (820-03830)
Medical Microinstruments, Inc.
GUDID#
Symani Accessories Master Clip - A device designed to be used to transiently hold sections of drape together or to a medical device/equipment during a surgical procedure. It is typically in the form of a curved blade or two joined blades. This is a single-use device.
2025-04-21
Symani Accessories Contoured Master Clip - A device designed to be used to transiently hold sections of drape together or to a medical device/equipment during a surgical procedure. It is typically in the form of a curved blade or two joined blades. This is a single-use device.
2025-04-21
Symani Accessories Master Holder - A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
2025-04-21
Scissors - A surgical device intended to be used in conjunction with a robotic surgical system to cut tissue or sutures during a robotic open-surgical procedure. It is designed as a long shaft with a pair of mechanical (i.e., not electrosurgical) cutting blades at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system. This is a single-use device.
2026-03-06
Forceps - A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a single-use device.
2026-03-06
Synaptix Plug B Type - 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.
2026-03-06
Symani Surgical Robot CMM Plug type "B" - An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
2025-04-21
Symani Surgical Robot Console - An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
2025-04-21
Symani Surgical Robot Console Flat - An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.
2025-04-21
Symani NanoWrist Instruments Micro Needle Holder - 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.
2025-04-21
Symani NanoWrist Instruments Micro Needle Holder Suture Cut - 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.
2025-04-21
Symani NanoWrist Instruments Micro Dilator - A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a single-use device.
2025-04-21
Symani NanoWrist Instruments SuperMicro Needle Holder - 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.
2025-04-21
Symani NanoWrist Instruments SuperMicro Dilator - A surgical device intended to be used in conjunction with a robotic surgical system to grasp tissue (typically atraumatically) or foreign bodies during a robotic endoscopic procedure. It is designed as a long shaft with a pair of scissors-like grasping tongs or claws at the distal end, and a proximal housing intended to be connected directly to an arm of the robotic surgical system; it is not an electrosurgical instrument. This is a single-use device.
2025-04-21
Symani NanoWrist Instruments SuperMicro Needle Holder Suture Cut - 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.
2025-04-21
Symani Accessories Instrument Connector - An adaptor intended to function as a connecting interface between a robotic surgical system articulated arm and an attached surgical instrument. This is a single-use device.
2025-04-21
Symani Accessories Master Clip - A device designed to be used to transiently hold sections of drape together or to a medical device/equipment during a surgical procedure. It is typically in the form of a curved blade or two joined blades. This is a single-use device.
2025-04-21
Symani Accessories Contoured Master Clip - A device designed to be used to transiently hold sections of drape together or to a medical device/equipment during a surgical procedure. It is typically in the form of a curved blade or two joined blades. This is a single-use device.
2025-04-21
Symani Accessories Master Holder - A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
2025-04-21