Product code EZO— Gastroenterology, Urology

FDA has cleared 5 devices under product code EZO between 1992 and 2000, filed by 4 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.

• 20001 clearance
• 19961 clearance
• 19951 clearance
• 19941 clearance
• 19921 clearance

• KARL STORZ Endoscopy-America, Inc.2 clearances
• Richard Wolf Medical Instruments Corp.1 clearance
• Olympus Corp.1 clearance
• Olympus America, Inc.1 clearance

• K000905 — URETHROTOME 8667.XXX AND 8670.XXXRichard Wolf Medical Instruments Corp.·2000-05-12
• K950719 — OES UROLOGYOlympus America, Inc.·1996-12-11
• K945686 — KARL STORZ KNIVES, CURETTESKARL STORZ Endoscopy-America, Inc.·1995-02-13
• K934730 — KARL STORZ ENDOSCOPIC COLD KNIFE BLADESKARL STORZ Endoscopy-America, Inc.·1994-01-11
• K904939 — FLEXIBLE AND RIGID URETEROTOME SYSTEMOlympus Corp.·1992-01-07