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.
Absorbable Gel For Intraoperative Use In Spine Surgery
Orthopedic
The Absorbable Gel for Intraoperative Use in Spine Surgery is a resorbable implant applied to nerve roots during spinal surgery after hemostasis has been achieved and prior to wound closure, intended to reduce postoperative pain and neurological symptoms as an adjunct to the surgical procedure. The gel resorbs over time and does not require a separate removal procedure. Classified as FDA Class 2 under regulation 888.3047, it requires 510(k) clearance in the Orthopedic specialty and is flagged as an implant. 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.