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510(k) K161010

HICP200 Patient/Monitor Interconnect Cable by Innerspace Neuro Solutions, Inc. — Product Code GWM

K161010 is an FDA 510(k) premarket notification submitted by Innerspace Neuro Solutions, Inc. for the device "HICP200 Patient/Monitor Interconnect Cable". The FDA issued a decision of Substantially Equivalent on October 20, 2016. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2016
Date Received
April 11, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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  • K182073 — BcSs-PICNI-2000 Sensor (October 17, 2019)

FDA data resources