Ultrasafe Plus Passive Needle Guard
FDA 510(k) K123743 · Safety Syringes, Inc.
510(k) numberK123743
Submission
- Device name
- Ultrasafe Plus Passive Needle Guard
- Applicant
- Safety Syringes, Inc.
Carlsbad, CA, US - Received
- December 6, 2012
- Decision date
- March 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEG – Syringe, Antistick
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code MEG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional | Methyl Co., Ltd. | 02/18/2026SE |
| K250847 | VaporShieldMEG · Traditional | Vault Paragon Group, Inc. | 12/12/2025SE |
| K230287 | SaviSafe Safety DeviceMEG · Traditional | Suzhou Savicred Biotechnology Co., Ltd. | 11/21/2023SE |
| K231165 | Shina Syringe; Shina Safety SyringeMEG · Traditional | Shina Med Corporation | 10/27/2023SE |
| K231907 | Medline Safety Insulin and TB SyringesMEG · Traditional | Medline Industries, LP | 10/18/2023SE |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | Cardinal Health200, LLC | 06/21/2023SE |
| K220114 | PowerPAK SyringeMEG · Traditional | Vault Paragon Group, Inc. | 01/25/2023SE |
| K221981 | SafeR Syringe and SafeR StingMEG · Traditional | Roncadelle Operations Srl | 12/29/2022SE |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 11/23/2022SE |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/01/2022SE |
More from Jiangsu Kangbao Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K122558 | Ultrasafe Passive Needle GuardMEG · Special | 09/20/2012SE |
| K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive…MEG · Traditional | 04/28/2006SE |
| K042712 | Tamper Evident Ultrasafe Passive Delivery SystemMEG · Special | 10/15/2004SE |
| K013801 | Ultrasafe Dental Injection SystemMEG · Special | 12/13/2001SE |
| K011369 | Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)MEG · Traditional | 05/29/2001SE |
| K972900 | Ultrasafe Model T200 InjectorFMF · Traditional | 02/26/1998SE |
| K972877 | Ultrasafe Injection System Model C200 Injector with Needle GuardFMF · Traditional | 02/26/1998SE |
| K972878 | Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225, and B300FMF · Traditional | 10/30/1997SE |
| K944425 | Ultrasafe Aspirating SyringeMEG · Traditional | 01/26/1995SE |
Questions and answers
When was Ultrasafe Plus Passive Needle Guard cleared by the FDA?
Ultrasafe Plus Passive Needle Guard (K123743) received a 510(k) decision of Substantially Equivalent on March 26, 2013, 110 days after the submission was received.
What is the product code of K123743?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.