Articulating Instrument Coupler, Needle Driver

Organization name

Asensus Surgical Italia S.r.l.

SRN

IT-MF-000007964

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 2 countries total.

Trade name

Articulating Instrument Coupler, Needle Driver

UDI-DI code

00815440022259

Basic UDI-DI

081544002TD006UP

Reference / catalog number

X9007759

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The Senhance Adapters are accessory devices used with the Asensus Surgical’s Senhance Surgical System (Senhance system). The Senhance system is a console based, multi-arm surgical system which enables a surgeon to remotely control surgical instrumentation during laparoscopic and thoracoscopic surgery. The Senhance Adapters are designed to provide the mechanism which allows the Senhance Surgical Instruments and endoscopes to interface with the robotic manipulator arms of the Senhance system. Each surgical instrument or endoscope is paired with a unique, corresponding adapter, which is laser-marked to facilitate matching with the associated device. The adapters include non-energized and energized designs for use with the Senhance passive, monopolar, and bipolar surgical instruments and compatible endoscope camera systems.

Additional information URL

https://ifu.asensus.com/

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z1202018099REMOTE CONTROL ROBOT-ASSISTED ENDOSCOPIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES - OTHER