510(k) K000212

KSEA CHARDONNES MORCELLATION KNIFE by KARL STORZ Endoscopy-America, Inc. — Product Code KOH

K000212 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KSEA CHARDONNES MORCELLATION KNIFE". The FDA issued a decision of Substantially Equivalent on April 21, 2000. The device falls under product code KOH (Instrument, Manual, General Obstetric-Gynecologic), a Class I device regulated under 21 CFR 884.4520. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.