Many companies out there are claiming they are FDA cleared when they are not. The minute a PDO thread is inserted into a cannula, it becomes a whole new device that requires its own FDA clearance. So while they may have a PDO thread clearance, if they are pre-loaded into a cannula or needle, this requires a whole new 510k submission. It is imperative to do your research when choosing a PDO thread company and always request to see their 510K documentation if you are unsure.