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510(k) K181750

SITZMARKS by Konsyl Pharmaceuticals — Product Code FFX

K181750 is an FDA 510(k) premarket notification submitted by Konsyl Pharmaceuticals for the device "SITZMARKS". The FDA issued a decision of Substantially Equivalent on November 15, 2018. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2018
Date Received
July 2, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

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FDA data resources