U&U Insulin Syringe with/without Safety Retractable Device
FDA 510(k) K152808 · U&U Medical Technology Co, Ltd.
510(k) numberK152808
Submission
- Device name
- U&U Insulin Syringe with/without Safety Retractable Device
- Applicant
- U&U Medical Technology Co, Ltd.
Changzhou, CN - Received
- September 28, 2015
- Decision date
- March 25, 2016
- 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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| K132553 | U&U Sterile Piston Syringe Without NeedleFMF · Traditional | 02/27/2014SE |
| K123162 | U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollFRG · Traditional | 02/26/2014SE |
| K132552 | U&U Sterile Hypodermic NeedleFMI · Traditional | 11/13/2013SE |
Questions and answers
When was U&U Insulin Syringe with/without Safety Retractable Device cleared by the FDA?
U&U Insulin Syringe with/without Safety Retractable Device (K152808) received a 510(k) decision of Substantially Equivalent on March 25, 2016, 179 days after the submission was received.
What is the product code of K152808?
The FDA product code is MEG – Syringe, Antistick, a Class II (moderate risk) device regulated under 21 CFR 880.5860.