510(k) K965040

INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL by Johnson & Johnson Medical, Inc. — Product Code HHW

K965040 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Medical, Inc. for the device "INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL". The FDA issued a decision of Substantially Equivalent on March 10, 1997. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575. Johnson & Johnson Medical, Inc. has at least 10 other 510(k) clearances on record.