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510(k) Data Aggregation

    K Number
    K220781
    Device Name
    ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter
    Manufacturer
    Allwin Medical Devices, Inc
    Date Cleared
    2023-05-05

    (414 days)

    Product Code
    EZN, LJE
    Regulation Number
    876.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allwin Medical Devices, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ARMADA Ureteral Dilator Set: Used for step by step dilatation of the intramural and ureter and / or for stone manipulation. ARMADA Nottingham One Step Dilator: Used for one step dilatation of the intramural portion and ureter. ARMADA Amplatz Renal Dilator Set: Used for progressive dilatation for tract prior to percutaneous kidney stone removal. ARMADA Renal Dilator: Used for dilatation of Renal Tract. Glider Amplatz Sheath: Used to maintain previously established nephrostomy tract. Fascial Dilator: Fascial Dilators are used for dilatation of percutaneous track over the guidewire. Introducer Sheath: Used for introducing safety wire during nephrostomy. Introducer Catheter: Used for guiding renal dilators for establishing nephrostomy tract.
    Device Description
    Not Found
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    K Number
    K220730
    Device Name
    allFlex Ureteral Catheters, Krait Ureteral Catheters
    Manufacturer
    Allwin Medical Devices, Inc
    Date Cleared
    2022-10-13

    (213 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allwin Medical Devices, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allwin Ureteral Catheters are used for drainage of urine from the ureter and they allow the delivery of contrast media.
    Device Description
    Not Found
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    K Number
    K203626
    Device Name
    SureStrip Vitrification Straw, SureLock Vitrification Straw
    Manufacturer
    Allwin Medical Devices, Inc
    Date Cleared
    2021-06-04

    (175 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allwin Medical Devices, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos. The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell stage embryos.
    Device Description
    Not Found
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    K Number
    K200248
    Device Name
    Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
    Manufacturer
    Allwin Medical Devices, Inc.
    Date Cleared
    2020-07-01

    (152 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allwin Medical Devices, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allwin Embryo Transfer Catheters are used to introduce in vitro fertilized (IVF) embryos into the uterine cavity. Allwin Embryo Transfer Catheters (Pro Embryo Trans, Pro Echo Trans, Twinkle Pro Embryo Trans, and Bulb Trans Star ETC) include stylets or soft obturators intended to assist in uterine access of the guide catheter during an embryo transfer procedure. Allwin Stylets and Soft Obturators are intended to be used with Allwin Embryo Transfer Catheters to assist in uterine access of the guide catheter during an embryo transfer procedure.
    Device Description
    Allwin ETC include the following models: Embryo Trans, Twinkle Embryo Trans, Bulb Trans Ultra, Bulb Trans Star, Pro Embryo Trans, and Twinkle Pro Embryo Trans Embryo Transfer Catheter. Allwin ETC Stylets and Soft Obturators include the following models: Stylet For Embryo Trans / Twinkle Embryo Trans, Stylet For Pro Embryo Trans / Pro Echo Trans / Twinkle Pro Embryo Trans, Stylet for Bulb Trans Ultra / Bulb Trans Star, Soft Obturator For Pro Embryo Trans / Twinkle Pro Embryo Trans Embryo Transfer Catheter.
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    K Number
    K190659
    Device Name
    Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
    Manufacturer
    Allwin Medical Devices, Inc.
    Date Cleared
    2019-12-02

    (263 days)

    Product Code
    FAD
    Regulation Number
    876.4620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allwin Medical Devices, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ALL WIN Ureteral stents are intended to temporarily facilitate drainage of urine from kidney to bladder by trained physician. The recommended target population is adults and pediatrics. The indwelling time should not exceed thirty (30) days.
    Device Description
    Not Found
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    K Number
    K190590
    Device Name
    Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
    Manufacturer
    Allwin Medical Devices, Inc.
    Date Cleared
    2019-11-25

    (263 days)

    Product Code
    MQE
    Regulation Number
    884.6100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allwin Medical Devices, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allwin Ovum Pickup Needles are used for laparoscopic or ultrasound guided transvaginal retrieval of oocytes from ovarian follicles.
    Device Description
    Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle).
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    K Number
    K190522
    Device Name
    Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
    Manufacturer
    Allwin Medical Devices, Inc.
    Date Cleared
    2019-11-14

    (255 days)

    Product Code
    MQF, MOF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Allwin Medical Devices, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allwin Intra Uterine Insemination Catheters are intended for the introduction of washed spermatozoa into the uterine cavity.
    Device Description
    Not Found
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