www.fdanews.com/articles/203598-fda-clears-palliares-surgical-end-200-tubeset
FDA Clears Palliare’s Surgical END-200 Tubeset
July 19, 2021
Palliare has received 510(k) clearance from the FDA for its END-200 endoscopic tubeset, which is used for insufflation — blowing a gas, powder or vapor into a body cavity — during surgical procedures.
The END-200 extends the capabilities of the company’s EVA15 continuous pressure insufflator from laparoscopic surgery to endoscopic and endoluminal surgery.
In combination with EVA15, the END-200 helps maintain the pressure in the presence of leaks during natural orifice surgery, the company said.