Ultimed Ulticare Safety Syringe
FDA 510(k) K080600 · Ultimed, Inc.
510(k) numberK080600
Submission
- Device name
- Ultimed Ulticare Safety Syringe
- Applicant
- Ultimed, Inc.
Minneapolis, MN, US - Received
- March 3, 2008
- Decision date
- June 25, 2008
- 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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| K213407 | UltiCare Disposable Pen NeedlesFMI · Traditional | 12/16/2021SE |
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| K100812 | Ulticare Disposable Pen NeedlesFMI · Traditional | 06/03/2010SE |
| 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 Ultimed Ulticare Safety Syringe cleared by the FDA?
Ultimed Ulticare Safety Syringe (K080600) received a 510(k) decision of Substantially Equivalent on June 25, 2008, 114 days after the submission was received.
What is the product code of K080600?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.