Product code EYZ— Gastroenterology, Urology

FDA has cleared 14 devices under product code EYZ between 1977 and 1997, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19971 clearance
• 19961 clearance
• 19952 clearances
• 19942 clearances
• 19931 clearance
• 19902 clearances
• 19893 clearances
• 19781 clearance
• 19771 clearance

• Travenol Laboratories, S.A.1 clearance
• Tecnol New Jersey Wound Care, Inc.1 clearance
• Spectrum Medsystems Corp.1 clearance
• Sierra Laboratories, Inc.1 clearance
• Researched, Novel Medical Devices (Rn/Md)1 clearance
• Patsy J. Trisler, J.D.1 clearance
• P.A.M., Inc.1 clearance
• Medline Industries, Inc.1 clearance
• Lsl Industries, Inc.1 clearance
• Latex Ind., Inc.1 clearance

• K964219 — ZIP CONDOM CATHETERGoulter Medical, Inc.·1997-08-11
• K961906 — UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018Spectrum Medsystems Corp.·1996-11-19
• K952780 — URINARY GEL DRAINAGE SYSTEMP.A.M., Inc.·1995-12-12
• K951597 — URINARY DRAINAGE BAGKey Medical Services, Inc.·1995-08-04
• K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINERResearched, Novel Medical Devices (Rn/Md)·1994-11-02
• K933126 — COMFORTCARE SYSTEMPatsy J. Trisler, J.D.·1994-02-25
• K930556 — NIGHT URINARY DRAINAGE BEDSIDE BAGEzmt Valve Co., Inc.·1993-05-14
• K896695 — DYNA-FLO URINARY DRAINAGE BAGMedline Industries, Inc.·1990-05-02
• K901000 — URO TEX URINALSSierra Laboratories, Inc.·1990-03-26
• K890465 — CLOSED SYSTEM URINARY DRAINAGE BAGCypress Medical Products, Ltd.·1989-05-23
• K891178 — TECNOL SECURE-ALL TUBE HOLDERTecnol New Jersey Wound Care, Inc.·1989-05-23
• K882714 — URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450Lsl Industries, Inc.·1989-01-31
• K780267 — CATH TRAY W/OUT CATHETERLatex Ind., Inc.·1978-02-24
• K772113 — URINARY DRAINAGE BAG 2D9017Travenol Laboratories, S.A.·1977-11-16