Tray, Irrigation, Sterile
FDA product code EYN · Class II (moderate risk) · 21 CFR 876.5980 · Gastroenterology, Urology
15510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944882 | Irrigation TrayEYN · Traditional | Clinical Resources, Inc. | 01/12/1995SE |
| K923941 | Irrigation Tray W/ Bulb Syringe & Sterile SalineEYN · Traditional | American Healthcare Corp. | 06/17/1993SEKD |
| K923940 | Irrigation Tray W/ Piston Syringe & Sterile SalineEYN · Traditional | American Healthcare Corp. | 06/17/1993SEKD |
| K923939 | Irrigation Tray W/ Bulb Syringe & Sterile WaterEYN · Traditional | American Healthcare Corp. | 06/17/1993SEKD |
| K923938 | Irrigation Tray W/ Piston Syringe & Sterile WaterEYN · Traditional | American Healthcare Corp. | 06/17/1993SEKD |
| K900148 | Kit Pak Irrigation TrayEYN · Traditional | Kit Pak, Inc. | 04/23/1990SEKD |
| K900737 | Piston Irrigation TrayEYN · Traditional | Orion Life Systems, Inc. | 04/19/1990SESK |
| K900736 | Bulb Irrigation TrayEYN · Traditional | Orion Life Systems, Inc. | 04/17/1990SESK |
| K801783 | Catheter Irrigation Trays, #3300, 3310 &EYN · Traditional | The Healthcare Group Laboratories, Inc. | 08/13/1980SE |
| K792082 | Gavage Feeding SetEYN · Traditional | Medical Devices, Inc. | 11/13/1979SE |
| K791020 | Fluid Administration Set FA-3160EYN · Traditional | Burron Medical Products, Inc. | 06/27/1979SE |
| K790607 | Greenline Irrigation TraysEYN · Traditional | Snyder Laboratories, Inc. | 05/11/1979SE |
| K781918 | Irrigator, Body CavityEYN · Traditional | Bci, Inc. | 02/15/1979SE |
| K781748 | Irrigation TrayEYN · Traditional | Intermed, Inc. | 12/12/1978SE |
| K760047 | Tray, Bladder IrrigationEYN · Traditional | M-C Ind., Inc. | 03/01/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3013-2024 Class II | Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D; 2) CYSTO…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2358-2019 Class II | Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe…Samples in the identified lot were found to have incomplete or open packaging seals. | Medline Industries Inc | 08/09/2019Open, Classified |
| Z-0238-2015 Class I | Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to…Customed products are being recalled because of compromised sterility, not limited to potentially damaged… | Customed, Inc | 10/08/2014Terminated |