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Canady Flex RoboWrist

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212736

by Us Medical Innovations, Llc

Identifiers

510(k) Number
K212736 FDA 510(k)
FDA Product Code
GCJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Canady Flex RoboWrist is a robotic surgical instrument designed for laparoscopic and open surgical procedures. It is classified under product code GCJ (Gastroenterology, Urology) and is intended to assist surgeons in performing precise, flexible manipulations within confined spaces during minimally invasive surgeries.

This device is supplied sterile and is intended for single-use. It is regulated under FDA 510(k) clearance (K212736) and is manufactured by US Medical Innovations, LLC. The RoboWrist features articulated wrist mechanics to enhance dexterity, and its design is intended for compatibility with standard laparoscopic ports and surgical settings.

Frequently asked questions

What types of surgical procedures is the Canady Flex RoboWrist intended to assist with, and how does its design support those procedures?

The Canady Flex RoboWrist is designed to assist surgeons in laparoscopic and open surgical procedures, particularly within the fields of gastroenterology and urology. Its articulated wrist mechanics provide enhanced dexterity, allowing for precise manipulations in confined spaces—ideal for minimally invasive surgeries where traditional instruments may lack flexibility. The device is compatible with standard laparoscopic ports, making it versatile for procedures requiring fine control and reach.

Is the Canady Flex RoboWrist reusable, or is it meant for single-use? How does this affect its use in a surgical setting?

The Canady Flex RoboWrist is explicitly intended for single-use only, as stated in its design and regulatory submission. This ensures sterility and reduces the risk of cross-contamination between patients. In a surgical setting, this means each procedure requires a new device, simplifying sterilization workflows and adhering to best practices for infection control.

How is the Canady Flex RoboWrist supplied, and what should clinicians consider when handling or storing it?

The device is supplied sterile, meaning it is pre-packaged and ready for immediate use without additional sterilization. Clinicians should store it in its original packaging to maintain sterility until the time of use. Since it is single-use, proper disposal protocols must follow local regulations after a single procedure to ensure compliance and safety.

What regulatory pathway does the Canady Flex RoboWrist follow, and how does this affect its availability or use in clinical settings?

The Canady Flex RoboWrist follows the FDA 510(k) clearance pathway, specifically with clearance number K212736, and is classified under product code GCJ (Gastroenterology, Urology). This means it has been determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. after clearance. Clinicians can rely on this pathway as evidence of its regulatory review, though they should always verify current compliance with the manufacturer or regulatory databases.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Us Medical Innovations - Canady Life Sciences, Us Medical Innovations, USMI Receives FDA Approval for New Robotic Surgery Device - The Canady ..., Canady Flex RoboWristTM - A SAGES Technology and Value Assessment

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Us Medical Innovations, Llc

Sources (1)

  • FDA 510(k) K212736 24 fields · synced Sep 19, 2026