EYN — Tray, Irrigation, Sterile Class II
FDA product code EYN covers "Tray, Irrigation, Sterile", a Class II medical device regulated under 21 CFR 876.5980. Submissions are reviewed by the Gastroenterology, Urology panel. At least 15 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EYN
- Device Class
- Class II
- Regulation Number
- 876.5980
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K944882 | clinical resources | IRRIGATION TRAY | January 12, 1995 |
| K923938 | american healthcare | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | June 17, 1993 |
| K923939 | american healthcare | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | June 17, 1993 |
| K923941 | american healthcare | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | June 17, 1993 |
| K923940 | american healthcare | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | June 17, 1993 |
| K900148 | kit pak | KIT PAK IRRIGATION TRAY | April 23, 1990 |
| K900737 | orion life systems | PISTON IRRIGATION TRAY | April 19, 1990 |
| K900736 | orion life systems | BULB IRRIGATION TRAY | April 17, 1990 |
| K801783 | healthcare group laboratories | CATHETER IRRIGATION TRAYS, #3300, 3310 & | August 13, 1980 |
| K792082 | medical devices | GAVAGE FEEDING SET | November 13, 1979 |
| K791020 | burron medical products | FLUID ADMINISTRATION SET FA-3160 | June 27, 1979 |
| K790607 | snyder laboratories | GREENLINE IRRIGATION TRAYS | May 11, 1979 |
| K781918 | bci | IRRIGATOR, BODY CAVITY | February 15, 1979 |
| K781748 | intermed | IRRIGATION TRAY | December 12, 1978 |
| K760047 | m-c ind | TRAY, BLADDER IRRIGATION | March 1, 1977 |