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.
Ligator, Esophageal
Gastroenterology, Urology
The Esophageal Ligator is an endoscopic device used during upper gastrointestinal endoscopy to apply elastic bands around esophageal varices or other mucosal lesions, causing them to necrose and slough off, thereby treating bleeding varices and reducing the risk of life-threatening hemorrhage in patients with portal hypertension. Classified as a Class 2 device under 21 CFR 876.4400 within the Gastroenterology and Urology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
510(k) Clearances
15 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.