510(k) K991323

SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR by Smith & Nephew, Inc. — Product Code FFS

K991323 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR". The FDA issued a decision of Substantially Equivalent on July 6, 1999. The device falls under product code FFS (Image, Illumination, Fiberoptic, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.