Catheter Irrigation Trays, #3300, 3310 &
FDA 510(k) K801783 · The Healthcare Group Laboratories, Inc.
510(k) numberK801783
Submission
- Device name
- Catheter Irrigation Trays, #3300, 3310 &
- Applicant
- The Healthcare Group Laboratories, Inc.
Mchenry, IL, US - Received
- July 28, 1980
- Decision date
- August 13, 1980
- 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 |
| 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 |
More from Burron Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850035 | Empty Solution Transfer ContainerKPE · Traditional | 06/07/1985SE |
| K842170 | Empty Solution Transfer ContainerKPE · Traditional | 10/19/1984SE |
| K842091 | Dispos. Acu-Cut Soft Tissue Biopsy · Traditional | 07/23/1984SE |
| K840742 | Right Atrial CatheterLJS · Traditional | 07/13/1984SE |
| K830299 | Solution Transfer ContainerKPE · Traditional | 02/19/1983SE |
| K822307 | Adhesive Spray #4050-4060KNX · Traditional | 09/24/1982SE |
| K822059 | Show'RbagLGF · Traditional | 07/22/1982SE |
| K821480 | Right Atrial Catheters Parenteral NutritDQY · Traditional | 06/17/1982SE |
| K821230 | Softic 49EBI · Traditional | 05/28/1982SE |
| K821162 | Adhesive RemoverKOX · Traditional | 05/14/1982SE |
Questions and answers
When was Catheter Irrigation Trays, #3300, 3310 & cleared by the FDA?
Catheter Irrigation Trays, #3300, 3310 & (K801783) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 16 days after the submission was received.
What is the product code of K801783?
The FDA product code is EYN – Tray, Irrigation, Sterile, a Class II (moderate risk) device regulated under 21 CFR 876.5980.