510(k) K980247

GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM by Gynex Corp. — Product Code HDC

K980247 is an FDA 510(k) premarket notification submitted by Gynex Corp. for the device "GYNEX IRIS HOOK, GYNEX ANGLE HOOK, GYNEX EMMETT TENACULUM". The FDA issued a decision of Substantially Equivalent on March 17, 1998. The device falls under product code HDC (Tenaculum, Uterine), a Class II device regulated under 21 CFR 884.4530. Gynex Corp. has at least 4 other 510(k) clearances on record.