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510(k) Data Aggregation
K Number
K250658Device Name
SureFine Pen Needle
Manufacturer
SHINA MED CORPORATION
Date Cleared
2025-04-03
(29 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SHINA MED CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.
Device Description
SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and needle cap with blister paper sealed on the opening hole of primary container.
The needle hub can be connected screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.
SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 31G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (EO gas sterilization), non-toxic, and non-pyrogenic. The pen needles are disposable, single use devices.
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K Number
K231165Device Name
Shina Syringe; Shina Safety Syringe
Manufacturer
Shina Med Corporation
Date Cleared
2023-10-27
(185 days)
Product Code
MEG, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shina Med Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Shina Syringe, Shina Safety Syringe is a plastic sterile syringe and hypodermic single lumen needle intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
Device Description
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is (not) included. lt is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
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K Number
K210848Device Name
Sure-Fine Insulin Syringes
Manufacturer
Shina Med Corporation
Date Cleared
2022-03-01
(344 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shina Med Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 expoxy.
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K Number
K191531Device Name
Sure-Fine Insulin Syringes
Manufacturer
Shina Med Corporation
Date Cleared
2019-09-06
(88 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shina Med Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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, 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 sizes and cap color. The modified Sure-Fine Insulin syringe is substantially equivalent to the predicate device (Sure-Fine Insulin Syringes, K152879). The biggest difference between the modified device and predicate device is the addition of needle gauge (27G) and the addition of needle length (1/4"). The devices operate in the principles of a piston syringe fluid path is sterile (EO gas sterilization), Non-toxic, Non-pyrogenic and single use disposable.
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K Number
K152879Device Name
Sure-Fine Insulin Syringes
Manufacturer
SHINA MED CORPORATION
Date Cleared
2016-09-09
(345 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SHINA MED CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 dose of U-100 insulin. The syringe has a graduated barrel, 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 sizes and cap color.
Category: U-100
Insulin syringe: 1/2cc and 1cc, 3/10cc, 1/2cc and 1cc
Needle Gauge: 28Gauge, 29Gauge, 30Gauge, 31Gauge
Needle Length: 1/2", 5/16"
Cap color: Needle cap: Orange, Plunger Cap: Orange or white
This device operates in the principles of a piston syringe fluid path is sterile (EO gas sterilization), single use disposable.
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K Number
K152877Device Name
SureFine Pen Needle
Manufacturer
SHINA MED CORPORATION
Date Cleared
2016-06-07
(251 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SHINA MED CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.
Device Description
The SureFine Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The pen needle consists of a needle, hub, and shield assembly. Blister paper covers primary container. The primary container maintains sterility of the needle because primary container covers the hub and the needle tube with blister paper sealed on the opening hole of primary container.
The needle hub can be connected with the pen. The hub has internal threads, which allows it to be screwed onto the pen. The needle shield is intended to provide physical protection to the needle tube.
The SureFine Pen Needle is offered in various gauges sizes (29G, 30G, 32G) and Lengths (4mm, 6mm, 8mm, 12.7mm). These are sterile (Eo gas sterilization) and non-pyrogenic. The pen needles are disposable, single use devices.
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