Anovo Robotic Control Unit (RCU)

FDA UDI

Class II (US FDA UDI)

by Momentis Surgical Ltd

Identity

Trade Name: Anovo Robotic Control Unit (RCU) FDA UDI
Generic Name: Endoscopic electromechanical surgical system FDA UDI
Device Name: The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system comprises Anovo Surgeon Console, two sterile instruments (Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Robotic Control Unit includes two Robotic Control Units permanently attached to each other by Momentis Surgical (cannot be separated by user). Robotic Control Unit contains brushed motors, sensors, drivers and the electronic board required to drive the Instrument ARMS. Each Robotic Control Unit drives one Arm. The two Robotic Control Units are mirrored and identical except for that the right Robotic Control Unit (RCU I) includes an adaptor that enables mounting of the Robotic Control Units Assembly to the Robotic Control Support System and a mechanism that controls the linear movement of the Robotic Control Units and Instrument ARM. The Robotic Control Units connect the Instrument ARMS to an electrosurgical generator. FDA UDI
Model / Reference: - FDA UDI
Description: The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system comprises Anovo Surgeon Console, two sterile instruments (Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). The Robotic Control Unit includes two Robotic Control Units permanently attached to each other by Momentis Surgical (cannot be separated by user). Robotic Control Unit contains brushed motors, sensors, drivers and the electronic board required to drive the Instrument ARMS. Each Robotic Control Unit drives one Arm. The two Robotic Control Units are mirrored and identical except for that the right Robotic Control Unit (RCU I) includes an adaptor that enables mounting of the Robotic Control Units Assembly to the Robotic Control Support System and a mechanism that controls the linear movement of the Robotic Control Units and Instrument ARM. The Robotic Control Units connect the Instrument ARMS to an electrosurgical generator. FDA UDI

Identifiers

Catalog Number: FP-02-0003 FDA UDI
Primary DI / UDI-DI: 07290018151044 FDA UDI
FDA Product Code: QNM FDA UDI
GMDN Term: Endoscopic electromechanical surgical system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4961 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic electromechanical surgical system

Anovo Robotic Control Unit (RCU) by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Momentis Surgical Ltd

Sources (1)

FDA UDI b77cc7aa-245a-4154-a87d-96b38e25639d 36 fields · synced Jun 8, 2026