510(k) K243820

Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 by Dornier Medtech America — Product Code FED

K243820 is an FDA 510(k) premarket notification submitted by Dornier Medtech America for the device "Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250". The FDA issued a decision of Substantially Equivalent on January 31, 2025. The device falls under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Dornier Medtech America has at least 10 other 510(k) clearances on record.