Product code EYN— Gastroenterology, Urology

FDA has cleared 15 devices under product code EYN between 1977 and 1995, filed by 11 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.

• 19951 clearance
• 19934 clearances
• 19903 clearances
• 19801 clearance
• 19794 clearances
• 19781 clearance
• 19771 clearance

• American Healthcare Corp.4 clearances
• Orion Life Systems, Inc.2 clearances
• The Healthcare Group Laboratories, Inc.1 clearance
• Snyder Laboratories, Inc.1 clearance
• Medical Devices, Inc.1 clearance
• M-C Ind., Inc.1 clearance
• Kit Pak, Inc.1 clearance
• Intermed, Inc.1 clearance
• Clinical Resources, Inc.1 clearance
• Burron Medical Products, Inc.1 clearance

• K944882 — IRRIGATION TRAYClinical Resources, Inc.·1995-01-12
• K923938 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERAmerican Healthcare Corp.·1993-06-17
• K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERAmerican Healthcare Corp.·1993-06-17
• K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEAmerican Healthcare Corp.·1993-06-17
• K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEAmerican Healthcare Corp.·1993-06-17
• K900148 — KIT PAK IRRIGATION TRAYKit Pak, Inc.·1990-04-23
• K900737 — PISTON IRRIGATION TRAYOrion Life Systems, Inc.·1990-04-19
• K900736 — BULB IRRIGATION TRAYOrion Life Systems, Inc.·1990-04-17
• K801783 — CATHETER IRRIGATION TRAYS, #3300, 3310 &The Healthcare Group Laboratories, Inc.·1980-08-13
• K792082 — GAVAGE FEEDING SETMedical Devices, Inc.·1979-11-13
• K791020 — FLUID ADMINISTRATION SET FA-3160Burron Medical Products, Inc.·1979-06-27
• K790607 — GREENLINE IRRIGATION TRAYSSnyder Laboratories, Inc.·1979-05-11
• K781918 — IRRIGATOR, BODY CAVITYBci, Inc.·1979-02-15
• K781748 — IRRIGATION TRAYIntermed, Inc.·1978-12-12
• K760047 — TRAY, BLADDER IRRIGATIONM-C Ind., Inc.·1977-03-01