04 Sep Anutra Medical Syringe Receives FDA 501k Approval
Improving a centuries-old device:
Our recent partnership with Anutra Medical in conjunction with Gilero Biomedical has resulted in the FDA approval and market launch of the Anutra Syringe.
Per Anutra Press Release:
“Morrisville, NC – In January 2015, Anutra Medical received 510k approval from the FDA on a new disposable, feedback aspiration syringe. This syringe is the first known innovation on the traditional, metal, one-handed aspiration dental syringe. Overcoming many shortcomings of the traditional dental syringes, Anutra Medical has developed a light, ergonomic, bulk-delivery, disposable dental syringe.
Until now, an aspiration dental syringe is limited to holding only one cartridge at a time. A cartridge is a small vial that typically holds 1.8 mL of fluid. Most dental restorative procedures require the use of multiple cartridges. As a result, Anutra Medical engineered the Anutra Feedback Aspiration Syringe® to hold up to 5 mL of fluid, a major innovation. To further enhance a clinician’s experience, the Anutra Feedback Aspiration Syringe® is designed with audible and haptic feedback. With the traditional metal syringe, it can be difficult to know just how much anesthetic is being injected into a patient.
With Anutra’s new syringe, it is easy for a clinician to both hear and feel a click for each milliliter that is being injected. Additionally, the Anutra Feedback Aspiration Syringe® is equipped with double-sided volume labeling to allow a dentist to easily see how much anesthetic is being administered regardless of the angle.”
-Anutra Medical, January 8, 2015
Our product and brand teams collaborated with Anutra on the industrial design of their Anutra Syringe conceptualization, CAD development, engineering collaboration, and prototype fabrication.