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.
Surgical Film
General, Plastic Surgery
The Surgical Film (product code OOD) is a Class 2 implantable surgical device regulated under 21 CFR 878.3300 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is intended to reinforce soft tissue or bone where weakness exists, support temporary wound healing, and reinforce urological, gynecological, or gastrointestinal soft tissues or hernia and fascial defects; it may also help minimize tissue attachment to the device upon contact with viscera. The device is flagged as both an implant and life-sustaining or life-supporting, indicating its critical reconstructive function.
510(k) Clearances
13 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.