www.fdanews.com/articles/204196-innovative-health-sciences-needle-sets-cleared
Innovative Health Sciences Needle Sets Cleared
August 31, 2021
Innovative Health Sciences has received the FDA’s 510(k) clearance for its Insignis subcutaneous needle sets.
The needle sets feature a channel that maintains the needle at a 90-degree insertion angle, and an audible and tactile wing closure that helps prevent needle stick injuries.
The Chester, N.Y.-based company received a CE mark and ISO certifications for its full Insignis syringe infusion system in recent weeks.