Greenline Irrigation Trays
FDA 510(k) K790607 · Snyder Laboratories, Inc.
510(k) numberK790607
Submission
- Device name
- Greenline Irrigation Trays
- Applicant
- Snyder Laboratories, Inc.
Mchenry, IL, US - Received
- March 29, 1979
- Decision date
- May 11, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EYN – Tray, Irrigation, Sterile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EYN
| 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 |
More from Medical Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K843906 | Snyder Hemovac Wound Drainage DevicesGBS · Traditional | 11/05/1984SE |
| K821321 | Snyder Debribement System LDP-1BTA · Traditional | 08/06/1982SE |
| K800861 | Snyder Hemovac Chest Drainage SolutionKDQ · Traditional | 05/02/1980SE |
| K800578 | Surgivac TMGCY · Traditional | 04/16/1980SE |
| K800577 | Snyder Hemovac TM Vented Wound KitGCY · Traditional | 04/16/1980SE |
| K800543 | Snyder Hysterectomy Y Tube KitGCY · Traditional | 04/16/1980SE |
| K800542 | 100 ML Snyder HemovacGCY · Traditional | 04/02/1980SE |
| K790606 | Catheters, Greenline SuctionBSY · Traditional | 04/23/1979SE |
| K790420 | Suction Connecting TubingBYY · Traditional | 04/23/1979SE |
| K790419 | Yankauer & Poodle Suction InstrumentsBYY · Traditional | 04/23/1979SE |
Questions and answers
When was Greenline Irrigation Trays cleared by the FDA?
Greenline Irrigation Trays (K790607) received a 510(k) decision of Substantially Equivalent on May 11, 1979, 43 days after the submission was received.
What is the product code of K790607?
The FDA product code is EYN – Tray, Irrigation, Sterile, a Class II (moderate risk) device regulated under 21 CFR 876.5980.