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.
Septal Stapler/Absorbable Staples
General, Plastic Surgery
The Septal Stapler/Absorbable Staples (product code OLL) is a Class 2 implantable device regulated under 21 CFR 878.4750 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is designed to approximate soft tissues using absorbable staples delivered via a pre-loaded stapler during nasal septal surgery, including procedures with or without cartilage reinsertion, to aid healing of the nasal septum. The device is flagged as an implant due to the absorbable staples placed within the nasal tissue, and it is not life-sustaining.
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.