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 Suturing Device For Altering Gastric Anatomy For Weight Loss
Gastroenterology, Urology
The Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss is a device used endoscopically to apply sutures that approximate and fold gastric tissue, restricting stomach volume and reducing caloric intake for the treatment of obesity. Unlike bariatric surgery, this approach is entirely endoscopic. Classified as FDA Class 2 under regulation 876.5983, it requires 510(k) clearance in the Gastroenterology and Urology specialty, and is flagged as an implant because the sutures remain in place in the gastric wall. It is not life-sustaining.
510(k) Clearances
2 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.