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.
Anal Fistula Closure Device
General, Plastic Surgery
The Anal Fistula Closure Device is a surgical implant intended for the repair and closure of anal fistulas. It may be manually applied or delivered with a delivery device, and is designed to promote healing of this challenging anorectal condition. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.4835 in the General and Plastic Surgery specialty. It carries product code QML and is flagged as an implant. It is not life-sustaining and is not GMP exempt.
510(k) Clearances
1 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.