510(k) K933216

KARL STORZ ENDOSCOPY-AMERICA, INC. by KARL STORZ Endoscopy-America, Inc. — Product Code FFS

K933216 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ ENDOSCOPY-AMERICA, INC.". The FDA issued a decision of Substantially Equivalent on September 9, 1993. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.