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510(k) K050272

CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS by Cryomedical Instruments, Ltd. — Product Code GXH

K050272 is an FDA 510(k) premarket notification submitted by Cryomedical Instruments, Ltd. for the device "CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 24, 2005. The device falls under product code GXH (Device, Surgical, Cryogenic), a Class II device regulated under 21 CFR 882.4250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2005
Date Received
February 4, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Surgical, Cryogenic
Device Class
Class II
Regulation Number
882.4250
Review Panel
NE
Submission Type

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FDA data resources