Product code BYZ— General Hospital

FDA has cleared 9 devices under product code BYZ between 1979 and 1993, filed by 8 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.

• 19931 clearance
• 19911 clearance
• 19901 clearance
• 19843 clearances
• 19822 clearances
• 19791 clearance

• Bemis Health Care2 clearances
• Warne Surgical Products, Ltd.1 clearance
• Triton Technology, Inc.1 clearance
• Microvasive1 clearance
• Medical Marketing Group1 clearance
• Medical Device Inspection Co., Inc.1 clearance
• Electromedics, Inc.1 clearance
• Delta Medical Industries1 clearance

• K925412 — ELECTROMEDICS TISSUE TRAP/ #TT280Electromedics, Inc.·1993-02-05
• K913643 — MUCOUS SPECIMEN TRAPMedical Device Inspection Co., Inc.·1991-10-10
• K902883 — TISSUE/POLYP TRAP SYSTEMTriton Technology, Inc.·1990-09-12
• K841409 — BUSH NECK W/PLUGWarne Surgical Products, Ltd.·1984-04-18
• K840253 — ONE-WAY AIR VALVEDelta Medical Industries·1984-04-05
• K834467 — SPECIMEN TRAPMicrovasive·1984-02-17
• K822556 — CRITICAL MEASUREMENT UNITBemis Health Care·1982-10-18
• K822557 — SPECIMEN ADAPTORBemis Health Care·1982-10-18
• K791847 — ASPRI-LUKEMedical Marketing Group·1979-10-02