Prism Medical & Design said today it won FDA 510(k) clearance for its ProteXsure Safety Capsule System designed to prevent accidental needle sticks.
The ProteXsure system contains 100 protective needle capsules designed to cover needle tips post-injection to prevent needle stick injuries for healthcare workers, caregivers, consumers and waste management workers, the Coral Springs, Fla.-based company said.
“The FDA clearance, awarded for the ProteXsure Safety Capsule System, is another indication of the Prism platform. We look forward to continuing our global launch and establishing our global footprint with exclusive partners in the protection of health care workers & consumers using our family of sharps safety devices,” managers Les Capella & Chip Starnes said in a press release.
The ProteXsure is automated and requires a single hand to operate, automatically advancing to the next capsule after each needle is inserted into the device and covered, Prism Med & Design said.
The device won CE Mark approval in the European Union this February, the company said.
