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510(k) K112915

SPIRTIUS CUFF INFLATION SYRINGE by Spiritus Technologies, LLC — Product Code BSK

K112915 is an FDA 510(k) premarket notification submitted by Spiritus Technologies, LLC for the device "SPIRTIUS CUFF INFLATION SYRINGE". The FDA issued a decision of Substantially Equivalent on May 25, 2012. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2012
Date Received
October 3, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

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  • K180991 — AG 100s (October 12, 2018)
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FDA data resources