Product code GCO— Gastroenterology, Urology

FDA has cleared 3 devices under product code GCO between 1979 and 1986, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19862 clearances
• 19791 clearance

• Simpson/Basye, Inc.1 clearance
• Johnson & Johnson Professionals, Inc.1 clearance
• Cytotech, Inc.1 clearance

• K862838 — CYTOTECH HSV IGG ENZYME IMMUNOASSAYCytotech, Inc.·1986-12-09
• K862717 — HAND MIRROR (ENDOSCOPE)Simpson/Basye, Inc.·1986-07-30
• K790340 — DELTA-ROLJohnson & Johnson Professionals, Inc.·1979-04-12