510(k) K983220

STRYKER INFRAVISION ESOPHAGEAL KIT by Stryker Endoscopy — Product Code FAT

K983220 is an FDA 510(k) premarket notification submitted by Stryker Endoscopy for the device "STRYKER INFRAVISION ESOPHAGEAL KIT". The FDA issued a decision of Substantially Equivalent on June 4, 1999. The device falls under product code FAT (Bougie, Esophageal, And Gastrointestinal, Gastro-Urology), a Class II device regulated under 21 CFR 876.5365. Stryker Endoscopy has at least 10 other 510(k) clearances on record.