Search Results
Found 2 results
510(k) Data Aggregation
K Number
K210864Device Name
Safety Pen Needle
Manufacturer
Date Cleared
2022-02-17
(331 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Sandstone Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The safety pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.
HE Model: Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
HS Model: Additionally, the product has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection end). The locked shields help reduce the occurrence of needle sticks from both ends of the needle.
Device Description
The proposed device, Safety Pen Needle, is a sterile, non-pyrogenic, single-use device, which is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. It incorporates a sharps injury prevention feature, which can reduce the occurrence of accidental needle sticks.
The proposed device is provided with two models, i.e. HE Model and HS Model. HE Model has an attached safety shield, which can automatically lock in place and reduce the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection. HS Model has two safety shields, which lock in place after use (patient end) and upon removal of the needle from the pen (pen connection-end). The locked shields help reduce the occurrence of accidental needle sticks from both ends of the needle.
Both of HE Model and HS Model contain main body, needle tube, front shield, rear shield, big spring, turning tube, container (outer cap) and peel tab (sealing paper). Both ends of the needle tube (i.e. the patient end and the pen connection end) is lubricated by silicone oil. The needle tube and the needle hub are bonded by glue. The container sealed with the peel tab constitutes the sterile barrier system. The common components of both models are almost the same in materials and structure and size, and the only difference is the structure of the rear shield. The biggest difference between the two models is that HS Model contains a small spring additionally and has a relatively more complex structure.
Ask a Question
Ask a specific question about this device
K Number
K193422Device Name
Easydrip Pen Needle, Easydrip Plus Pen Needle
Manufacturer
Date Cleared
2021-02-02
(421 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Sandstone Medical (Suzhou) Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Device Description
The proposed devices, Pen Needles, are a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. The proposed devices include two models, i.e. Easydrip Pen Needle and Easydrip Plus Pen Needle. Both models have the same construction, operation methods and similar materials. Both models consist of needle tubing, needle tip shield, needle base, needle container, sealing dialysis paper, glue and silicone oil. The needle base of the device can be screwed onto compatible insulin pens. The only minor differences between the Easydrip and Easydrip Plus models are the outer shape and the material of the Needle tip shield. The Easydrip Needle tip shield is slightly shorter in length and more tapered than the Easydrip Plus Needle tip shield. The material of construction of the Easydrip Needle tip shield is polyethylene, while the Easydrip Plus Needle tip shield is polypropylene.
The Pen Needles are offered in various gauge sizes and needle lengths. The proposed devices are irradiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-9.
Ask a Question
Ask a specific question about this device
Page 1 of 1