FDA 483 - Oscor, Inc.

This document is a 510(k) premarket notification clearance letter issued by the FDA to Oscor, Inc. for their SafeSept™ Transseptal Trocar Guidewire. The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing its marketing subject to general controls and other applicable regulations. The letter outlines various regulatory requirements the firm must comply with, including registration, listing, good manufacturing practices, and labeling.