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.
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Gastroenterology, Urology
The Endoscopic Suture/Plication System for Gastroesophageal Reflux Disease (GERD) (product code ODE) is a gastroenterology and urology device used endoscopically to treat chronic GERD symptoms by either approximating tissue with sutures or plicating (folding) tissue with an implanted fastener, reinforcing the lower esophageal sphincter area. The procedure is performed without open surgery. This device is FDA Class 2 under regulation 876.1500 in the Gastroenterology, Urology specialty, requires 510(k) clearance, and carries an implant flag indicating that a tissue-plicating component is left in the body.
510(k) Clearances
20 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.