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AnovoTM Instrument ARMS

FDA UDI

Class II (US FDA UDI)

by Momentis Surgical Ltd

Identity

Trade Name
AnovoTM Instrument ARMS FDA UDI
Generic Name
Robotic electrosurgical instrument, bipolar/monopolar FDA UDI
Device Name
The Anovo 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 composed of Anovo Surgeon Console, two sterile instruments (Anovo 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 Anovo Instrument ARMS are the system’s components that are inserted transvaginally into the pelvic cavity to manipulate the tissue and perform the surgery. Two identical Instrument ARMS are connected to the Robotic Control Units, each of which corresponds to the respective hand of the surgeon as controlled by right or left Controllers. The two Arms utilized with the Anovo System are identical and provide identical capabilities. The end effector, located at the end of the flexible section, provides grasping and electrosurgical capabilities. The Instrument Arm is a sterile disposable component. It is ETO sterilized and provided to the user within a plastic tray packaged in a sterile pouch. Instrument ARMS Packed with Cannula Seal & ARMS Entry Guide Seal FDA UDI
Model / Reference
- FDA UDI
Description
The Anovo 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 composed of Anovo Surgeon Console, two sterile instruments (Anovo 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 Anovo Instrument ARMS are the system’s components that are inserted transvaginally into the pelvic cavity to manipulate the tissue and perform the surgery. Two identical Instrument ARMS are connected to the Robotic Control Units, each of which corresponds to the respective hand of the surgeon as controlled by right or left Controllers. The two Arms utilized with the Anovo System are identical and provide identical capabilities. The end effector, located at the end of the flexible section, provides grasping and electrosurgical capabilities. The Instrument Arm is a sterile disposable component. It is ETO sterilized and provided to the user within a plastic tray packaged in a sterile pouch. Instrument ARMS Packed with Cannula Seal & ARMS Entry Guide Seal FDA UDI

Identifiers

Catalog Number
FP-01-0001 FDA UDI
Primary DI / UDI-DI
17290018151096 FDA UDI
FDA Product Code
QNM FDA UDI
GMDN Term
Robotic electrosurgical instrument, bipolar/monopolar 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Robotic electrosurgical instrument, bipolar/monopolar

AnovoTM Instrument ARMS by Momentis Surgical Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Robotic electrosurgical instrument, bipolar/monopolar.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Momentis Surgical Ltd

Sources (1)

  • FDA UDI c1e91172-4c71-4d0a-a91e-2d0c2573e7bc 36 fields · synced May 30, 2026