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Found 518 results
510(k) Data Aggregation
(194 days)
Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle
Regulation Number: 21 CFR 880.5570
|
| Classification | 21CFR 880.5570
Suzhou) Inc. | No change |
| Product Code | FMI | FMI | No change |
| Regulation Number | 21 CFR 880.5570
| 21 CFR 880.5570 | No change |
| Classification | Ⅱ | Ⅱ | No change |
| Type of use | Single
The pen needle is intended for use with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs.
Easydrip Pen Needles are single-use, sterile, and non-pyrogenic medical device designed to be used with pen injector devices for subcutaneous injection of fluids and FDA-approved drugs. The subject devices include four models, i.e. Easydrip Classic, Easydrip Classic Pro, Easydrip Plus, and Easydrip Plus Pro. All models have the same operation methods and similar materials. The device comprises a stainless needle, needle hub, inner cap, outer cap and sealing paper, and the needle surface coated with silicone oil. The needle hub of the device can be screwed onto compatible pen injector devices.
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(183 days)
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(120 days)
315031
China
Re: K253622
Trade/Device Name: Safety Pen Needle
Regulation Number: 21 CFR 880.5570
Name: Safety Pen Needle
Regulation Name: Hypodermic single lumen needle
Regulation Number:21 CFR 880.5570
Pen Needle | Safety Pen Needle | / |
| Product Code | FMI | FMI | Same |
| Regulation Number | 21 CFR 880.5570
| 21 CFR 880.5570 | Same |
| Indications for use | The Safety pen needle is intended for use with pen
The Safety pen needle is intended for use with pen injector devices for subcutaneous injection of drugs. It has sharps protection feature of the patient-end and cartridge-end. For Model SD, the needle tube tip is 3 bevel. For Model SDW, the needle tube tip is 5 bevel.
Safety Pen Needle, could be divided into Model SD and Model SDW.
Model SD/SDW consists of needle hub,shield sleeve,rear spring,front spring, slider, inner shell,protective jacket,needle tube,outer container and seal(dialysis paper).
Safety Pen Needle,could be divided into two models according to the needle tube tip is 3 or 5 bevel; the needle tube is thin-wall. Although the product of different model have different needle tube tip, but the same is that a double-ended needle tube is fixed with needle hub, the needle tip is protected by a protective jacket, the product is sealed with medical dialysis paper and needle container. The device is sterilized by EO gas and for single use. The shelf life is 5 years. The device is non-toxic and non-pyrogenic.
Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with protective jacket before use, medical dialysis paper is covered and sealed needle container to maintain sterile of the device. The cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.
Safety Pen Needle has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end and cartridge end of the needle due to the effect of safe-lock guard.
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(230 days)
** Piston Syringe; Hypodermic Single Lumen Needle
Regulation Numbers: 21 CFR 880.5860; 21 CFR 880.5570
models) | N/A |
| K Number | K252098 | K113422 | N/A |
| Regulation Number | 21 CFR 880.5860; 21 CFR 880.5570
| 21 CFR 880.5570; 21 CFR 880.5860 | Same |
| Product Code | MEG, FMI | MEG, FMI | Same |
| Indications
This product is designed for medical applications, specifically to administer injections or extract body fluids. It can be used to inject drug solutions into tissues or aspirate body fluids. To prevent the possibility of needle pricks, the safety device can be engaged to secure the injection needle within a removable outer sleeve.
The PA3X Detachable Safety Sleeve Syringe is a sterile, single-use manual piston syringe with an integrated hypodermic needle and a manually activated safety mechanism intended to reduce the risk of needlestick injuries following use.
The device consists of:
- Polypropylene barrel
- Polypropylene plunger
- Rubber gasket
- Polypropylene needle hub
- Stainless steel needle
- Needle cap
- Polypropylene detachable outer sleeve safety mechanism
Following injection or aspiration, the outer sleeve is manually advanced to cover and lock over the needle to provide post-use sharps protection.
The device is available in:
- 3 mL (23G × 1-inch needle)
- 5 mL (23G × 1-inch needle)
The device is sterilized using ethylene oxide and supplied sterile for single use.
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(305 days)
AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
Regulation Number: 21 CFR 880.5570
Delivery Needles
Manufacturer: Asistan Medikal, (Gaziantep, Turkey)
Regulation Number: 21 CFR 880.5570
Depot, LLC (Chapel Hill, NC, USA)
Regulatory Class: Class II
Regulation Number: 21 CFR 880.5570
Used for percutaneous administration of diagnostic allergenic extracts.
The Medblue Skin Prick Test Applicator is a sterile, single use disposable, multiple test head applicator used to administer skin test substances to the surface of the skin.
The Medblue Skin Prick Test Applicator is used for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies.
The Medblue Skin Prick Test Applicator is offered in several configurations with 1, 8, 10 or 12 test heads made of medical grade acrylic (ps158N) material arranged in a symmetrical design. Model AS 113 features a metal tip made of 301 stainless steel. All other models have acrylic tips.
Each of the test heads have a "leg". At the tip of each leg is an array of protruding test points (tines). Each leg has 1, 6, or 9 tines. The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin. Each leg has a stopper to prevent going deeper than the epidermis thickness.
The test heads are designed to fit into the matching asymmetrical well design of a dipwell tray. The applicator loads the allergen from each well in the tray onto each test head.
When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the test heads of each applicator. The applicator is not intended to pierce the skin.
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(118 days)
Stoneham, Massachusetts 02180
Re: K252886
Trade/Device Name: Pen Needle
Regulation Number: 21 CFR 880.5570
Devices
Predicate Device:
510(k) Number: K220129
Product Code: FMI
Classification: 21 CFR 880.5570
Reference Device:
510(k) Number: K230635
Product Code: FMI
Classification: 21 CFR 880.5570
; no impact on safety or effectiveness. |
| Product Code | FMI | FMI | Same |
| Regulation number | 880.5570
| 880.5570 | Same |
| Classification Name | Hypodermic Single Lumen Needle | Hypodermic Single Lumen
Pen Needles are sterile, single use needles intended for using with pen injector devices for the injection of drug.
The Pen Needle is a sterile, single use device intended for use with pen injector devices for the subcutaneous injection of drug. The device is available in ordinary and safety configurations.
The following are the types of needles:
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Ordinary Type I, Ordinary Type IB, Ordinary Type VIA, Ordinary Type VIB, and Ordinary Type VIC needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, and seal paper.
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Safety Type IIA, Safety Type IIB, and Safety Type IIIA needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, spring, and seal paper.
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Safety Type IIIB, Safety Type VII, Safety Type VIII, and Safety Type IX needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, spring, and seal paper.
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Safety Type IV needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear inner core, spring, and seal paper.
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Safety Type V and Safety Type X needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, spring, rear spring and seal paper.
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Ordinary Type XI needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, adjusting sleeve and seal paper.
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Safety Type XII needle consists of needle hub, double-ended needle tube, which is bonded with the needle hub with joining medium, needle container, needle shield, needle cover, inner core, rear needle shield, adjusting sleeve, spring, rear spring and seal paper.
The needle shield and rear needle shield provide physical protection to the needle tube before and after use. The needle container together with seal paper forms the primary sterile barrier system and protects the needle hub. The hub is designed to be securely screwed onto the needle-based injection system (e.g. pen injector) for the subcutaneous injection of drug.
The product is individually packaged and sterilized by irradiation to achieve a sterility assurance level (SAL) of 10⁻⁶. It is intended for single use only.
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(84 days)
Trade/Device Name: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
Regulation Number: 21 CFR 880.5570
Name:** Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
Classification Regulation: 21 CFR 880.5570
Maxcon Sharps Container | N/A |
| Product code | MMK | MMK | MMK | Same |
| Regulation No. | 21 CFR 880.5570
| 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | II | same |
| Indications for Use |
Gongdong sharps Containers (SCR-01Q, SCR-01G, SCR-03G) are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
Gongdong sharps container (SCR-01Q, SCR-01G, SCR-03G) are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers.
The Sharps Container constructed of polypropylene plastic. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable, and stable.
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(267 days)
Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Regulation(s): 880.5860; 880.5570
------|------------|--------------|---------------|----------------|
| PowerPAK Syringe | 880.5860; 880.5570
| Device Name | VaporShield | PowerPAK™ Syringe | |
| Regulation Number | 21 CFR 880.5860 / 21 CFR 880.5570
| 21 CFR 880.5860 / 21 CFR 880.5570 | Same |
| Device Classification | Class II | Class II | Same |
The VaporShield™ is a sterile, single-use, closed system transfer device (CSTD), incorporating a preassembled Drug Vial holder (DVH) and Syringe (1mL, 22GA). The preassembled device is intended for medication draw from a drug vial only. After medication draw, the DVH is removed from the syringe, and the syringe is used for direct injection of hazardous and non-hazardous medication via subcutaneous or intramuscular administration. The syringe incorporates a safety mechanism which automatically retracts the needle inside the device for drug containment, and prevention of accidental needlesticks and device reuse. The VaporShield mechanically prevents drug transfer external to the device to minimize individual and environmental drug exposure. The VaporShield is intended for use by medical professionals who prepare/administer injection(s) to adults and adolescents in healthcare facilities. The device is not intended for neonates (<28 days old), infants (< 2 yrs old), or children (> 2 yrs. old – 12 yrs. old). The VaporShield Device is not intended for Compounding, Reconstitution, Phlebotomy, Intravenous injection, Intraperitoneal injection, or Intrathecal injection.
The VaporShield closed system transfer device (CSTD) is sterile, for single use, and is intended for direct injection of hazardous or nonhazardous drugs. A single configuration includes a 1 mL syringe, 22G cannula, and is pre-assembled with a Drug Vial Holder (DVH). Preassembly of the syringe and drug vial holder components are interlocked via a flex tab snap-fit connection. During drug draw, the DVH ensures a stable connection between the drug vial and syringe. The VaporShield has three (3) settings, two for needle length, and one (1) for safety. The DVH can be removed from the syringe when the syringe is placed in locked setting.
The VaporShield includes a safety mechanism that is manually activated by full plunger depression. When activated, the safety mechanism retracts the needle inside the plunger rod for containment, preventing accidental needlestick, and disallowing device reuse.
Syringe is intended for parenteral injection (subcutaneous / intramuscular).
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(120 days)
K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
Regulation Number: 21 CFR 880.5570
Device Regulatory Classification: Class II
Device Classification Regulation: 21 CFR 880.5570
This device is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.
The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.
The K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (here in after K-SHIELD Advantage HP-PAIS) is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.
The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.
This device has a Huber needle for insertion into the septum of an implanted port, for infusion and blood sampling through the port. This needle is equipped with wings of a specific shape and rigidity to ensure that the user can securely hold the device during needle insertion and withdrawal. Additionally, the alignment of the gripping position and the puncture point along a straight line supports accurate puncture placement. The device features a safety mechanism that activates upon needle withdrawal, with a safety shield covering the needle tip.
The activation of the safety mechanism is audibly confirmed by a click sound. Moreover, the device is equipped with high-pressure resistant tubing and clamp, enabling the supply of medications such as contrast media using an automatic injector.
Specification
| Needle gauge | Needle length | Tube length (mm) |
|---|---|---|
| 19G | 3/4" | w/o Y site: 170 |
| With Y site: 100/100 | ||
| 1" | w/o Y site: 170 | |
| With Y site: 100/100 | ||
| 20G | 3/4" | w/o Y site: 170 |
| With Y site: 100/100 | ||
| 1" | w/o Y site: 170 | |
| With Y site: 100/100 | ||
| 22G | 3/4" | w/o Y site: 170 |
| With Y site: 100/100 | ||
| 1" | w/o Y site: 170 | |
| With Y site: 100/100 |
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(259 days)
Re: K250700
Trade/Device Name: Pen Injector Needle 32.5
Regulation Number: 21 CFR 880.5570
Hypodermic single lumen needle
Classification Panel: General Hospital
Regulation: 21 CFR 880.5570
The Pen Injector Needle 32.5 is indicated for use with a pen injector device for patients who require the subcutaneous injection of drugs including insulin and human growth hormone as a therapy.
The Pen Injector Needle 32.5 consists of a cannula, needle hub, inner needle cap, outer needle case and seal film. The outer needle case and seal film function as the primary packaging and maintain the sterility when unopened.
The Pen Injector Needle 32.5 is a manually operated, disposable device intended for single use only. The device is individually packaged and sterilized by electron beam. The primary package consists of an outer needle case and sealing film.
The cannula is made of stainless steel and it is Thin Walled. The cannula remains 32.5G throughout the needle length, as a straight hypodermic needle. The cannula is pointed at both the patient interface end, for injection into the patient's body tissue, and the cartridge interface end, to puncture the cartridge for drug delivery.
The Pen Injector Needle 32.5 is available in different needle lengths. The length of the needle patient side (from the glue mount on the hub to the tip of the patient interface end) ranges from 4 mm (5/32") to 8 mm (5/16"). The patient interface end (needle tip) features a 3-bevel, asymmetrical needle edge.
The cartridge interface end is attached to a plastic hub (needle hub) which screws onto a compatible pen injector (not supplied with this device). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case).
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