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Found 587 results
510(k) Data Aggregation
(267 days)
is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 880.5860
The Extension tube is intended as a connecting line for injection of a contrast and saline during coronary angiography procedures.
The Extension tube is made up of connectors, male and/or female luer, caps and tubing, with the maximum injection pressure of 1200psi, as a connecting line for direct injection of contrast media or saline. It is single use and supplied sterile by Ethylene Oxide.
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(154 days)
Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe
Regulation Number: 21 CFR 880.5860
Piston syringe
Product Code: FMF, MEG
Device Class: II
Regulation Number: 21 CFR 880.5860
single lumen needle | Same |
| 6 | Product Code | FMF | FMF | Same |
| 7 | Regulation Number | 21 CFR 880.5860
| 21 CFR 880.5860 | Same |
| 8 | Review Panel | General Hospital | General Hospital | Same |
| 9 | Device
| 21 CFR 880.5860 | Same |
|---|-------------------|------------------|------------------|------|
|
Profoject™ Insulin Syringes (Model A):
The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Profoject™ Insulin Syringes (Model B):
The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Profoject™ Safelock Disposable Insulin Syringe:
The device is intended for the delivery of U-40 or U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.
Profoject™ Insulin Syringes: Profoject™ Insulin Syringes are categorized into Model A and Model B, the difference is that Model A utilizes an integrated hub and barrel design, and Model B has a separate hub and barrel. The proposed device are 0.3mL, 0.5mL, and 1mL syringes designed for subcutaneous injection of a desired dose of insulin, consisting of needle cap, needle tube, plunger stopper, plunger, barrel and hub (only Model B). Profoject™ Insulin Syringes are sterile, single-use, non-toxic and work on the principle of a piston syringe.
Profoject™ Safelock Disposable Insulin Syringe: The Profoject™ Safelock Disposable Insulin Syringe are 0.3mL, 0.5mL, and 1mL syringes designed for subcutaneous injection of a desired dose of insulin, consisting of needle cap, needle tube, plunger stopper, plunger, barrel, collar and protective shield. The Profoject™ Safelock Disposable Insulin Syringe is a sterile, single-use, non-toxic and work on the principle of a piston syringe.
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(168 days)
Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe
Regulation Number: 21 CFR 880.5860
syringe |
| Product Code | QNQ, MEG |
| Device Class | II |
| Regulation Number | 21 CFR 880.5860
| 21 CFR 880.5860 | Same |
Page 9
| Parameters | Proposed Device | Predicate Device | Remark |
| 21 CFR 880.5860 | Same |
| 8 | Review Panel | General Hospital | General Hospital | Same |
| 9
| 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| 7 | Review Panel | General Hospital | General Hospital
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is used to inject fluids into, or withdraw fluids from, the body.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin. The Sharps Injury Prevention Feature (SIPF) is designed to aid in the prevention of needle stick injuries and syringe reuse.
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe consists of a barrel with a Luer Slip or Luer Lock connector which comply with ISO 80369-7, a plunger, and a plunger stopper. The device is available in 0.5 mL and 1 mL capacities. It is sterile, single-use, and non-toxic device that operates on the principle of a piston syringe.
Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle: Profoject™ Low Dead Space Syringe with Needle/ Profoject™ Tuberculin Syringe with Needle is sterile, single-use device. Each consists of either a Luer slip or Luer lock syringe assembly integrated with a pre-attached needle, and the syringe is available in two capacities (0.5mL and 1mL). For each capacity variant, the pre-attached needle is available in the following gauge specifications: 16G, 18G, 19G, 21G, 22G, 23G, 25G, 27G and 30G.
Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle: Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.
Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe: Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe is sterile, single-use, non-toxic devices that work on the principle of a piston syringe, and the syringes are available in three capacities: 0.3mL, 0.5mL, and 1mL. Each capacity variant is equipped with a permanently attached needle, available in the following gauge specifications: 21G, 23G, 25G, 26G, 27G, 28G, 29G, 30G and 31G.
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(230 days)
Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
Regulation Number: 21 CFR 880.5860
Classification Name:** Piston Syringe; Hypodermic Single Lumen Needle
Regulation Numbers: 21 CFR 880.5860
Hypodermic Syringe with Safety Needle
510(k) Number: K113422
Regulation Numbers: 21 CFR 880.5860
series (multiple 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 |
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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(27 days)
Massachusetts 01730
Re: K253769
Trade/Device Name: Instylla Delivery Kit
Regulation Number: 21 CFR 880.5860
- Syringe, Piston
Classification Name: Piston syringe
Classification Regulation: 21 CFR 880.5860
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline, and other aqueous solutions.
The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link). The barrel contains a fixed male luer connector, which is compatible with female luer hubs.
The Instylla Delivery Kit is a sterile, single patient use device intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions. The device consists of a double-barreled syringe holder which holds and couples two (2) 1mL commercially available needleless syringes with calibrated hollow barrels and movable plungers. A single plunger clip is attached to both syringe plungers to facilitate the simultaneous injection of two distinct fluids when depressed.
The syringes of the Instylla Delivery Kit are composed of polycarbonate. The plunger clip and holder are composed of Acrylonitrile Butadiene Styrene (ABS).
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(128 days)
Re: K252518**
Trade/Device Name: DuoprossTM Smart Cap (Type I)
Regulation Number: 21 CFR 880.5860
Device 510(k):** K252518
Device Common Name: Tamper Evident Cap
Regulation Number: 21 CFR 880.5860
Device 510(k):** K210818
Device Common Name: Tamper Evident Cap
Regulation Number: 21 CFR 880.5860
Smart Caps are indicated for use as sterile tip caps with tamper-evident function for luer-lock syringes. The use time of the Smart cap should be ≤ 24 hours.
The Smart Cap is a tamper-evident syringe cap with a clear indication of cap removal to ensure sterility and reduce the risk of medical fluids being compromised accidentally or intentionally. Its assembly includes an outer cover, an inner cap and an inner ring. It is made of acrylonitrile butadiene styrene (ABS) and polypropylene (PP) and is sterilized by ethylene oxide.
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(267 days)
, Idaho 83714
Re: K250847
Trade/Device Name: VaporShield
Regulation Number: 21 CFR 880.5860
Syringe, Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Regulation(s): 880.5860
----------------|------------|--------------|---------------|----------------|
| PowerPAK Syringe | 880.5860
-----------------|
| 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 |
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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(246 days)
with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
Regulation Number: 21 CFR 880.5860
with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle
Regulation Number: 21 CFR 880.5860
Common Name:** Syringe with Needle
Classification Name: Piston syringe
Regulation Number: 880.5860
Disposable Syringe with Safety Needle
Classification Name: Piston syringe
Regulation Number: 880.5860
regarding healthcare professional use and patient population while maintaining compliance with 21 CFR 880.5860
These devices are intended to be used:
- to inject fluids into, or withdraw fluids from, the body.
- to administer and/or withdraw (aspirate) fluids/drugs.
These devices are intended for use by qualified healthcare professionals in a professional healthcare environment. These devices are intended for use in the general population, including both adult and pediatric patients of all age groups, as determined appropriate by the qualified healthcare professional using the device.
EXEL Disposable Syringes are piston syringes of a three-piece design, consisting of a barrel, plunger, and gasket. The tip of the syringe has a male connector (nozzle) for connection to other devices. The barrel includes bold, clear scale markings (graduations) for accurate dosage measurement. The EXEL Disposable Syringe models are differentiated by volume (Luer Lock, Luer Slip, or Luer Slip Eccentric). and by the type of connector at the syringe tip (Luer Lock, Luer Slip). Luer Slip connectors may be centric or eccentric (i.e., off-centered) with a push-on design, while Luer Lock connectors provide a secure threaded attachment to needles or other devices. Some models feature extended graduation markings beyond the nominal capacity, differentiated with smaller graduation marks.
EXEL Hypodermic Needles are single-lumen hypodermic needles which are sterile and intended for single use. They consist of a hollow, bevel-edged metal tube (the cannula) that is sharpened at one end and joined to a female connector (the hub) at the other end. The EXEL Hypodermic Needle models are differentiated by needle gauge and needle length.
EXEL Disposable Syringes with Needles consist of a piston syringe connected to a hypodermic needle. The models are differentiated by the needle gauge, needle length, syringe volume, and connection type (Luer Lock, Luer Slip, or permanently attached).
The EXEL Disposable Syringe with SecureTouch Safety Needle features a manually activated safety shield that covers the needle tip immediately after withdrawal to reduce the risk of needlestick injury.
All subject devices are operated manually.
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(321 days)
K250192**
Trade/Device Name: Verisafe Safety Retractable Insulin Syringes
Regulation Number: 21 CFR 880.5860
Retractable Insulin Syringes |
| Classification Name | Piston Syringe |
| Regulation Number | 21 CFR 880.5860
was to be distinguished for difference indication. |
| Classification name | Piston Syringe (21 CFR 880.5860
Verisafe Safety Ret retractable Insulin Syringes are intended for aspiration and subcutaneous injection of insulin. After injection, the needle can be retracted directly from the patient's skin into the syringe barrel to avoid exposure to a contaminated needle, thereby minimizing accidental needle stick injuries.
Safety Retractable Insulin Syringes is a sterile device consisting of a calibrated barrel, plunger, piston, push button, retraction cylinder, sealing ring, spring and a needle. It is made of plastic, stainless steel and silicone materials. Type 5 is a syringe with a fixed needle.
The needle cap color is used to indicate insulin concentration that red for U40 and orange for U100.
Safety Retractable Insulin Syringes is using plunger to fill syringe as well as discharge the fluid. After use, by continuing to press the push-button down to depress the plunger all of the way within the barrel, the safety mechanism will be triggered, then the needle tube, needle hub and retraction cylinder will be retracted into the barrel completely under the force of the spring to minimize the risk of accidental sharps injury.
Product is delivered sterile. Sterilization process is validated according to EN ISO 11135.
This is a single-use device. Safety Sterile Syringes is intended to be used in Professional Healthcare Facility,
Home Environment and Transport (Ambulatory) Environment.
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(158 days)
Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
Regulation Number: 21 CFR 880.5860
Piston Syringe |
| Classification Name: | Ophthalmic Syringe |
| Regulation Number: | 21 CFR 880.5860
SC250AN, SC250LS, SC250LL | SC250AN, SC250LS, SC250LL | Identical |
| Regulation Number | 21 CFR 880.5860
| 21 CFR 880.5860 | Identical |
| Product Code(s) | QLY, FMF, FMI | QLY, FMF, FMI | Identical |
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
The StaClear Syringe is a sterile, single-use, manually operated piston syringe intended for general-purpose aspiration and injection of fluids by trained healthcare professionals. It is suitable for ophthalmic applications, including intravitreal injections. The syringe functions using standard positive-displacement mechanics, in which movement of the plunger creates pressure differentials to aspirate or expel fluid.
The StaClear Syringe is offered in the following configurations:
- SC250AN: Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and optional plunger cap.
- SC250LS: Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper.
- SC250LL: Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.
All three configurations were previously cleared under K243936. This submission introduces no changes to the device's design, dimensions, materials, or intended use. The only modification is the addition of a rigid PETG tray sealed with a Tyvek lid as an alternative sterile barrier packaging configuration.
The device's intended use, design, materials, sterilization method (EO), and labeled shelf life (5 years) remain unchanged.
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