Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sure-Fine Insulin Syringes

K-Number: K191531 · 2019-09-06

ApplicantShina Med Corporation
Decision Date2019-09-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sure-Fine Insulin Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Shina Med Corporation. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191531. 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 2019-09-06. The listed applicant is Shina Med Corporation. The 510(k) number is K191531.

When did Sure-Fine Insulin Syringes receive FDA 510(k) clearance?

Sure-Fine Insulin Syringes received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191531.

Who is the listed applicant for Sure-Fine Insulin Syringes?

The FDA 510(k) record lists Shina Med Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sure-Fine Insulin Syringes?

The FDA product code for Sure-Fine Insulin Syringes is FMF.

Other records listing Shina Med Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250510Sure-Fine Insulin SyringesK250658SureFine Pen NeedleK231165Shina Syringe; Shina Safety SyringeK210848Sure-Fine Insulin SyringesK152879Sure-Fine Insulin SyringesK152877SureFine Pen Needle

View all 7 devices →

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.

↑