510(k) K955119

SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES by Symbiosis Corp. — Product Code HIH

K955119 is an FDA 510(k) premarket notification submitted by Symbiosis Corp. for the device "SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES". The FDA issued a decision of Substantially Equivalent on January 18, 1996. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Symbiosis Corp. has at least 10 other 510(k) clearances on record.