Senhance Surgical System

System, Surgical, Computer Controlled Instrument

Asensus Surgical, Inc.

The following data is part of a premarket notification filed by Asensus Surgical, Inc. with the FDA for Senhance Surgical System.

Pre-market Notification Details

Device IDK220889
510k NumberK220889
Device Name:Senhance Surgical System
ClassificationSystem, Surgical, Computer Controlled Instrument
Applicant Asensus Surgical, Inc. 1 TW Alexander Drive, Suite 160 Durham,  NC  27703
ContactCasey Hinckley
CorrespondentCasey Hinckley
Asensus Surgical, Inc. 1 TW Alexander Drive, Suite 160 Durham,  NC  27703
Product CodeNAY  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-28
Decision Date2022-05-27

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