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510(k) Data Aggregation

    K Number
    K193619
    Device Name
    Cry-Ac®, Cry-Ac-3®, Cry-Baby
    Date Cleared
    2020-03-25

    (90 days)

    Product Code
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    Brymill Cryogenic Systems

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cry-Ac® Cryosurgical Devices and Accessories are intended for use as cryosurgical tools in the field of dermatology. The Cry-Ac® Cryosurgical Devices and Accessories are indicated for: · Ablation or freezing of skin cancers and other cutaneous disorders · Destruction of skin tags, warts or lesions, angiomas, sebaceous hyperplasia, basal cell carcinoma, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, actinic and sebortheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin
    Device Description
    The Cry-Ac® Cryosurgical Devices (Cry-Ac-38, and Cry-Baby®) are hand-held, refillable, cryosurgical devices which dispense pressurized liquid nitrogen via open spray and closed probe applicators. The cryosurgical devices are provided in three (3) sizes: 4 oz (125 mL; Cry-Baby®), 10 oz (300 mL, Cry-Ac-3®), and 16 oz (500 mL; Cry-Ac®). The open spray applicators include apertures, bent and straight spray extensions (1 in and 3 in), and cryochambers (6 mm to 18 mm) in various gauges. The probe applicators include mini probes (1 mm to 6 mm), conical probes (1 mm to 6 mm), ball probes (6 mm to 3 cm) and flat probes (8 mm to 3 cm). Additional accessories include a back-vent adapter, luer lock adapter, malleable extension, and right-angle and 45° adapters. The apertures are manufactured from brass, the probes are manufactured from stainless steel and brass, and coated with Teflon. Extension tubing is manufactured from silicon. The Cry-Ac® Cryosurgical Devices, open spray and closed probe applicators, and adapters are provided non-sterile and are autoclavable.
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