Ulticare Safety Syringe with Removable Needle
FDA 510(k) K140949 · Ultimed Incorporated
510(k) numberK140949
Submission
- Device name
- Ulticare Safety Syringe with Removable Needle
- Applicant
- Ultimed Incorporated
Minneapolis, MN, US - Received
- April 14, 2014
- Decision date
- February 9, 2015
- 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
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| 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 |
|---|---|---|
| K213407 | UltiCare Disposable Pen NeedlesFMI · Traditional | 12/16/2021SE |
| K100812 | Ulticare Disposable Pen NeedlesFMI · Traditional | 06/03/2010SE |
| K080600 | Ultimed Ulticare Safety SyringeMEG · Traditional | 06/25/2008SE |
| K081449 | Ultiguard Home Insulin Pen Needle Dispenser and Sharps ContainerMMK · Traditional | 06/03/2008SE |
| K062702 | Ulticare Disposable Syringes and NeedlesFMF · Traditional | 11/29/2006SE |
| K050464 | Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2FMI · Traditional | 05/11/2005SE |
| K033794 | Ulticare Disposable Syringe 3 Ml/CcFMF · Special | 12/30/2003SE |
| K021983 | Ulti Guard Home Insulin Syringe ContainerMMK · Traditional | 09/16/2002SE |
| K994230 | Ulticare Disposable SyringeFMF · Traditional | 03/24/2000SE |
Questions and answers
When was Ulticare Safety Syringe with Removable Needle cleared by the FDA?
Ulticare Safety Syringe with Removable Needle (K140949) received a 510(k) decision of Substantially Equivalent on February 9, 2015, 301 days after the submission was received.
What is the product code of K140949?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.