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510(k) K231661

CryoThin™ Surgical System and Accessories by Medinux (Tianjin) Technologies Co., Ltd. — Product Code GEH

K231661 is an FDA 510(k) premarket notification submitted by Medinux (Tianjin) Technologies Co., Ltd. for the device "CryoThin™ Surgical System and Accessories". The FDA issued a decision of Substantially Equivalent on November 27, 2023. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 2023
Date Received
June 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type

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FDA data resources