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510(k) Data Aggregation
K Number
K250510Device Name
Sure-Fine Insulin SyringesManufacturer
Date Cleared
2025-10-15
(236 days)
Product Code
Regulation Number
880.5860Type
SpecialPanel
General HospitalReference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
Device Description
Sure-Fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with epoxy.
The syringes are available in the following size and cap color.
| Category | Insulin Syringe | Needle gauge | Needle length | Cap Color |
|---|---|---|---|---|
| Needle Cap | ||||
| U-100 | 1 cc | 27 Gauge | 1/2″ | Orange |
| 1 cc | 27 Gauge | 5/16″ | ||
| 1/2cc and 1 cc | 28 Gauge | 1/2″ | ||
| 1/2cc and 1 cc | 28 Gauge | 5/16″ | ||
| 3/10cc, 1/2cc and 1 cc | 29 Gauge | 1/2″ | ||
| 3/10cc, 1/2cc and 1 cc | 29 Gauge | 5/16″ | ||
| 3/10cc, 1/2cc and 1 cc | 30 Gauge | 1/2″ | ||
| 3/10cc, 1/2cc and 1 cc | 30 Gauge | 5/16″ | ||
| 3/10cc and 1/2cc | 30 Gauge | 1/4″ | ||
| 3/10cc, 1/2cc and 1 cc | 31 Gauge | 5/16″ | ||
| 3/10cc and 1/2cc | 31 Gauge | 1/4″ |
AI/ML Overview
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