Sterile Irrigating Syringes, Kits,Tray
FDA 510(k) K813027 · Welcon, Inc.
510(k) numberK813027
Submission
- Device name
- Sterile Irrigating Syringes, Kits,Tray
- Applicant
- Welcon, Inc.
Mchenry, IL, US - Received
- October 28, 1981
- Decision date
- November 20, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6960
- Specialty
- General Hospital
Other 510(k)s with product code KYZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201877 | OtoSet- Ear Cleaning SystemKYZ · Traditional | Safkan, Inc. | 11/05/2020SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | Micromedics, Inc. | 03/15/2011SE |
| K092022 | Tissu Trans Harvest TubingKYZ · Special | Shippert Medical Technologies Corp. | 08/17/2009SE |
| K050797 | Tissu-TransKYZ · Traditional | Shippert Medical Technologies Corp. | 07/13/2005SE |
| K991254 | QS Delivery SystemKYZ · Traditional | Sub-Q, Inc. | 08/23/1999SE |
| K982435 | Irrigation Syringe KitKYZ · Traditional | Sub-Q, Inc. | 11/06/1998SE |
| K974288 | Zerowet SplashieldKYZ · Traditional | Zerowet, Inc. | 01/29/1998SE |
| K964833 | Rmi Dual Fluid Irrigating SyringeKYZ · Traditional | Research Medical, Inc. | 02/19/1997SE |
| K960725 | Marpp Pressure Monitoring SystemKYZ · Traditional | Paradigm Medical, Inc. | 07/15/1996SE |
| K960212 | CPR Irrigation TrayKYZ · Traditional | Custom Pack Reliability | 04/01/1996SE |
More from Custom Pack Reliability
| 510(k) | Device | Decision |
|---|---|---|
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | 05/01/2001SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | 02/05/1998SE |
| K971764 | Welcon Hue-Vu Urinary Drainage BagKNX · Traditional | 07/29/1997SE |
| K912869 | Women and Infant's Delivery PackHFW · Traditional | 12/04/1991SE |
| K904158 | Accorde(R) Irrigating Syringe/Procedure TrayFCM · Traditional | 11/29/1990SEKD |
| K894397 | Welcon Light HandleFTA · Traditional | 08/10/1989SE |
| K830359 | Sterile Catherization Procedure TraysKOD · Traditional | 03/17/1983SE |
Questions and answers
When was Sterile Irrigating Syringes, Kits,Tray cleared by the FDA?
Sterile Irrigating Syringes, Kits,Tray (K813027) received a 510(k) decision of Substantially Equivalent on November 20, 1981, 23 days after the submission was received.
What is the product code of K813027?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.