Search Results
Found 1 results
510(k) Data Aggregation
K Number
K193619Device Name
Cry-Ac®, Cry-Ac-3®, Cry-Baby
Manufacturer
Date Cleared
2020-03-25
(90 days)
Product Code
Regulation Number
878.4350Why 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.
Ask a Question
Ask a specific question about this device
Page 1 of 1