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Found 48 results
510(k) Data Aggregation
K Number
K012277Device Name
PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2002-02-11
(207 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Portex Ring Pessaries provide vaginal support to prevent the uterus from descending. Designed to ease uterine prolapse. Ring Pessaries are also used to correct other uterine displacements and to alleviate stress incontinence by pressure through the anterior vaginal wall onto the urethra.
Device Description
A ring pessary made from PVC or Polythene, available in various sizes, designed to ease uterine prolapse, and provide vaginal support to prevent the uterus from descending.
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K Number
K011907Device Name
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM
Manufacturer
SIMS LEVEL 1, INC.
Date Cleared
2001-12-18
(183 days)
Product Code
DWJ
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
SIMS LEVEL 1, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Snuggle Warm 4000 Convective Warming System is intended for thermal regulating a patient's temperature to prevent hypothermia by a warm air heated blanket system to reduce cold discomfort during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
Device Description
The Snuggle Warm consists of a disposable single use warming blanket that is placed in contact with the patient and a warming unit with a hose end temperature control connected to the blanket. The warming unit generates warm air that is distributed throughout the warming blanket to warm the patient during and after surgical procedures. It is intended for use by appropriately trained healthcare professionals in clinical environments.
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K Number
K012068Device Name
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2001-08-03
(32 days)
Product Code
MQE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wallace Oocyte Retrieval Set is intended for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles.
The Wallace Oocyte Retrieval Sets are sterile, single-use intended for ultrasound-guided, transvaginal collection of oocytes for ovarian follicles.
Device Description
Wallace Oocyte Retrieval Set is a single-use device provided sterile for ultrasound-guided, transvaginal recovery and collection of oocytes from ovarian follicles. The set consists of a single-lumen, stainless steel needle attached to polyurethane (Tecoflex) tubing 750mm long, using a 25mm long medical grade silicone sleeve. The needle is 33cm in length and available in 16 gauge or 17 gauge, each having echomarking at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. Tubing is attached to the hub of the needle and protrudes a total distance of 700mm until it passes through a silicone bung and terminates in an ABS female luer connector. FEP tubing for suction also protrudes through the bung, and at the other end terminates in a polypropylene luer lock connector.
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K Number
K011925Device Name
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO
Manufacturer
SIMS PORTEX, INC.
Date Cleared
2001-07-12
(22 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.
Device Description
This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device is an integral component of the device as it comes pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the needle bevel by swiveling the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately be disposed into a sharps container. This device is not designed for use with a luer lock syringe. The device is supplied with 25G, 26G, 27G needles both with and without a syringe.
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K Number
K010426Device Name
PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
Manufacturer
SIMS DELTEC, INC.
Date Cleared
2001-03-08
(23 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
SIMS DELTEC, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002201Device Name
ELECTROSTATIC HYDROPHOBIC BREATHING FILTER
Manufacturer
SIMS PORTEX, INC.
Date Cleared
2001-02-05
(200 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002506Device Name
BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
Manufacturer
SIMS PORTEX, INC.
Date Cleared
2000-12-14
(121 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001764Device Name
HOTLINE 2 FLUID WARMER
Manufacturer
SIMS LEVEL 1, INC.
Date Cleared
2000-08-09
(58 days)
Product Code
LGZ
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SIMS LEVEL 1, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001555Device Name
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2000-08-02
(76 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001318Device Name
CPAP SYSTEM, MODEL 102001
Manufacturer
SIMS PORTEX, INC.
Date Cleared
2000-07-20
(85 days)
Product Code
BYE
Regulation Number
868.5965Why did this record match?
Applicant Name (Manufacturer) :
SIMS PORTEX, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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