Sure-Fine Insulin Syringes
K-Number: K250510 · 2025-10-15
ApplicantShina Med Corporation
Decision Date2025-10-15
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Sure-Fine Insulin Syringes is a medical device manufactured by Shina Med Corporation. It received FDA 510(k) clearance on 2025-10-15 under approval number K250510. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sure-Fine Insulin Syringes?
Sure-Fine Insulin Syringes is a medical device that received FDA 510(k) clearance on 2025-10-15. It is manufactured by Shina Med Corporation. The 510(k) number is K250510.
When was Sure-Fine Insulin Syringes approved by the FDA?
Sure-Fine Insulin Syringes received FDA 510(k) clearance on 2025-10-15, under approval number K250510.
What company makes Sure-Fine Insulin Syringes?
Sure-Fine Insulin Syringes is manufactured by Shina Med Corporation.
What is the FDA product code for Sure-Fine Insulin Syringes?
The FDA product code for Sure-Fine Insulin Syringes is FMF.
Other Devices by Shina Med Corporation
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.