510(k) K971498

APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE by Applied Medical Resources — Product Code EZB

K971498 is an FDA 510(k) premarket notification submitted by Applied Medical Resources for the device "APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on May 5, 1997. The device falls under product code EZB (Stylet For Catheter, Gastro-Urology), a Class I device regulated under 21 CFR 876.5130. Applied Medical Resources has at least 10 other 510(k) clearances on record.