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510(k) Data Aggregation
K Number
K062318Device Name
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
Manufacturer
BIOTOP TECHNOLOGY CO., LTD.
Date Cleared
2007-01-03
(147 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOTOP TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HookSafe™ U-100 Insulin Syringe; models 0.5cc/ml and 1cc/ml, serves as the vehicle in which medication, insulin can be injected into the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.
Device Description
The HookSafe™ U-100 Insulin Syringe is the Safety Syringe with the following functional advantage:
<A> Single use, completely non-reusable, all parts and components can be safely discarded.
<B> Fully meets anti-needlestick requirements and incorporates anti-reuse functionality. After the injection of insulin, it is at this stage where the anti-reuse function of our syringe begins, a mechanism within our syringe engages the needle hub and forms a lock. At this point, one simply needs to pull the syringe plunger back and the needle will be completely retracted into the barrel of the syringe. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.
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K Number
K043038Device Name
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
Manufacturer
BIOTOP TECHNOLOGY CO., LTD.
Date Cleared
2004-12-22
(48 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOTOP TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.
Device Description
The HookSafe™ LUER-LOCK series is the Safety Syringe with the following functional advantage: <A> Single use, completely non-reusable, all parts and components can be safely inoperative and safely discarded. <B> Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, after the injection process, the syringe plunger should be fully depressed to ensure complete injection of the serum. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages the syringe needle and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the barrel of the syringe. Because the needle, when retracted, is in a stably-tilted position and forced against the inner shoulder of the syringe barrel. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.
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K Number
K041970Device Name
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
Manufacturer
BIOTOP TECHNOLOGY CO., LTD.
Date Cleared
2004-08-03
(12 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOTOP TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may help to prevent needlestick injuries as well as help to prohibit syringe reuse.
Device Description
The HookSafe™ series is the Safety Syringe with the following functional advantage:
- The syringe and components can be completely self-destroyed and safely discarded.
- Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, the syringe plunger should be fully depressed to ensure complete injection into the bloodstream. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the syringe. Because the needle, when retracted, is in a safely tilted pose against the inner shoulder of the syringe, the syringe becomes completely harmless and fully meets its anti-reuse functionality.
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K Number
K032747Device Name
BIOTOP DJT-A SAFETY SYRINGE
Manufacturer
BIOTOP TECHNOLOGY CO., LTD.
Date Cleared
2004-05-11
(250 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
BIOTOP TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIOTOP DJT-A Safety Syringe (3cc/mL) serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.
Device Description
The BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe that is very similar to a traditional syringe, except it possesses an integral needle retracting mechanism. Upon employing traditional syringe injection techniques, the needle can be manually retracted back inside the syringe barrel.
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