510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
General, Plastic Surgery
An electromechanical surgical system wherein both the surgeon and the user interface can be in the sterile field is a software-controlled electromechanical platform with fully positionable patient/device interfaces for minimally invasive surgical procedures, uniquely allowing both the surgeon and the primary control interface to transiently have sterile field presence as needed for the clinical context of use. It is classified as FDA Class II (510(k) required) under regulation 878.4965 in the General and Plastic Surgery specialty, with product code SDD. The device is not an implant and does not support life-sustaining functions.
510(k) Clearances
4 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.