510(k) K012869

GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 by Gimmi GmbH — Product Code HIH

K012869 is an FDA 510(k) premarket notification submitted by Gimmi GmbH for the device "GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25". The FDA issued a decision of Substantially Equivalent on March 11, 2002. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Gimmi GmbH has at least 5 other 510(k) clearances on record.