510(k) K021856

PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX by Porges S.A. — Product Code EYB

K021856 is an FDA 510(k) premarket notification submitted by Porges S.A. for the device "PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX". The FDA issued a decision of Substantially Equivalent on October 17, 2002. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Porges S.A. has at least 10 other 510(k) clearances on record.