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510(k) Data Aggregation
K Number
K091721Device Name
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
Manufacturer
Date Cleared
2009-10-02
(113 days)
Product Code
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
NEW MEDICAL TECHNOLOGIES GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To destroy tissue during surgical procedures by applying extreme cold.
Device Description
The CRYOSUCCESS is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying cold gas (nitrous oxide, N₂O). The device is based on direct application of nitrous oxide in the liquid phase to the selected treatment area. The N₂0 gas is delivered to the treatment site at -89° C to effect cellular destruction (necrosis). CRYOSUCCES functions by means of heat evaporation upon phase transition, where liquid nitrous oxide (N₂O, laughing gas) is applied to the treatment area by means of a capillary tube at a constant temperature of -89°C (cold performance) followed by evaporation. The treatment may be invasive.
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