Splash Guard
FDA 510(k) K905173 · E.M. Adams
510(k) numberK905173
Submission
- Device name
- Splash Guard
- Applicant
- E.M. Adams
Medfield, MA, US - Received
- November 16, 1990
- Decision date
- April 25, 1991
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K971948 | Patient RestraintFMQ · Traditional | 08/06/1997SE |
| K971536 | Restraints (Vests and Jackets)FMQ · Traditional | 07/01/1997SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | 03/21/1991SE |
| K873978 | Disposable Bipolar ForcepsGEN · Traditional | 11/23/1987SE |
| K850063 | Instrument Pocket · Traditional | 02/21/1985SE |
| K843724 | I.V. Start Kit & Obstetrical KitKKX · Traditional | 01/10/1985SE |
| K843783 | Wet PackEFQ · Traditional | 12/19/1984SE |
| K843782 | Dry TrayEFQ · Traditional | 12/13/1984SE |
| K843723 | Sterile Instrument Trays-VariousFSM · Traditional | 10/23/1984SE |
| K843115 | Sterile Solution BowlKDD · Traditional | 09/07/1984SE |
Questions and answers
When was Splash Guard cleared by the FDA?
Splash Guard (K905173) received a 510(k) decision of Substantially Equivalent on April 25, 1991, 160 days after the submission was received.
What is the product code of K905173?
The FDA product code is KYZ – Syringe, Irrigating (Non Dental), a Class I (low risk) device regulated under 21 CFR 880.6960.