Product code EYN
- Device name
- Tray, Irrigation, Sterile
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5980
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944882 | IRRIGATION TRAY | Clinical Resources, Inc. | 1995-01-12 |
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | American Healthcare Corp. | 1993-06-17 |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | American Healthcare Corp. | 1993-06-17 |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | American Healthcare Corp. | 1993-06-17 |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | American Healthcare Corp. | 1993-06-17 |
| K900148 | KIT PAK IRRIGATION TRAY | Kit Pak, Inc. | 1990-04-23 |
| K900737 | PISTON IRRIGATION TRAY | Orion Life Systems, Inc. | 1990-04-19 |
| K900736 | BULB IRRIGATION TRAY | Orion Life Systems, Inc. | 1990-04-17 |
| K801783 | CATHETER IRRIGATION TRAYS, #3300, 3310 & | The Healthcare Group Laboratories, Inc. | 1980-08-13 |
| K792082 | GAVAGE FEEDING SET | Medical Devices, Inc. | 1979-11-13 |
| K791020 | FLUID ADMINISTRATION SET FA-3160 | Burron Medical Products, Inc. | 1979-06-27 |
| K790607 | GREENLINE IRRIGATION TRAYS | Snyder Laboratories, Inc. | 1979-05-11 |
| K781918 | IRRIGATOR, BODY CAVITY | Bci, Inc. | 1979-02-15 |
| K781748 | IRRIGATION TRAY | Intermed, Inc. | 1978-12-12 |
| K760047 | TRAY, BLADDER IRRIGATION | M-C Ind., Inc. | 1977-03-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10889942587919 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2021-07-27 |
| 10888277841796 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-11-07 |
| 10888277992580 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-11-07 |
| 40888277841797 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-11-07 |
| 10889942133376 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-11-07 |
| 10889942276943 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-11-07 |
| 10889942403325 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-11-07 |
| 10888277007178 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-09-29 |
| 10888277582972 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-09-29 |
| 10889942130559 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-09-29 |
| 10889942147632 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2016-09-29 |
| 10815112020016 | Fluid Administration Set | Bracco Diagnostics Inc. | 2016-09-19 |