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Canady Flex RoboWrist

by Us Medical Innovations, LLC

510(k) K212736

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212736 Date22 Nov 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GCJ
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code GCJ (Laparoscope, General & Plastic Surgery).

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