Irrigation Tray W/ Bulb Syringe & Sterile Water
FDA 510(k) K923939 · American Healthcare Corp.
510(k) numberK923939
Submission
- Device name
- Irrigation Tray W/ Bulb Syringe & Sterile Water
- Applicant
- American Healthcare Corp.
South Plainfield, NJ, US - Received
- August 5, 1992
- Decision date
- June 17, 1993
- Decision
- Unknown (SEKD)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
More from Burron Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043543 | Blood Glucose Monitoring SystemNBW · Traditional | 04/08/2005SE |
| K043512 | Easygluco IGM-0002 G2CGA · Traditional | 04/08/2005SE |
| K031501 | Easygluco, Model IGM0002NBW · Traditional | 10/16/2003SE |
| K924192 | I.V. Start Kit (AHC-50-54954KGX · Traditional | 08/27/1993SEKD |
| K923941 | Irrigation Tray W/ Bulb Syringe & Sterile SalineEYN · Traditional | 06/17/1993SEKD |
| K923940 | Irrigation Tray W/ Piston Syringe & Sterile SalineEYN · Traditional | 06/17/1993SEKD |
| K923938 | Irrigation Tray W/ Piston Syringe & Sterile WaterEYN · Traditional | 06/17/1993SEKD |
| K924193 | Tracheostomy Care Set W/ Hydro PEROX(AHC-20-54685)BTO · Traditional | 06/16/1993SEKD |
| K924191 | Tracheostomy Care Set with Gloves and Extra TowelBTO · Traditional | 04/02/1993SESK |
| K924195 | Tracheostomy Care Set W/Forceps & Gauze Trach DresBTO · Traditional | 01/06/1993SE |
Questions and answers
When was Irrigation Tray W/ Bulb Syringe & Sterile Water cleared by the FDA?
Irrigation Tray W/ Bulb Syringe & Sterile Water (K923939) received a 510(k) decision of Unknown on June 17, 1993, 316 days after the submission was received.
What is the product code of K923939?
The FDA product code is EYN – Tray, Irrigation, Sterile, a Class II (moderate risk) device regulated under 21 CFR 876.5980.