Zerowet Splashield
FDA 510(k) K974288 · Zerowet, Inc.
510(k) numberK974288
Submission
- Device name
- Zerowet Splashield
- Applicant
- Zerowet, Inc.
Palos Verdes Peninsula, CA, US - Received
- November 14, 1997
- Decision date
- January 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K952407 | Redi Nurse System (RNS) Pre-Filled 10CC, 30CC, 60CC Syringe W/Sterile WaterKYZ · Traditional | Contour Fabricators of Florida, Inc. | 08/07/1995SE |
Questions and answers
When was Zerowet Splashield cleared by the FDA?
Zerowet Splashield (K974288) received a 510(k) decision of Substantially Equivalent on January 29, 1998, 76 days after the submission was received.
What is the product code of K974288?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.