SMARTRELEASE Endoscopic Soft Tissue Release System

Arthroscope

MicroAire Surgical Instruments

The following data is part of a premarket notification filed by Microaire Surgical Instruments with the FDA for Smartrelease Endoscopic Soft Tissue Release System.

Pre-market Notification Details

Device IDK211297
510k NumberK211297
Device Name:SMARTRELEASE Endoscopic Soft Tissue Release System
ClassificationArthroscope
Applicant MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville,  VA  22911
ContactGlenn Gerstenfeld
CorrespondentGlenn Gerstenfeld
MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville,  VA  22911
Product CodeHRX  
Subsequent Product CodeEMF
Subsequent Product CodeKCT
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-28
Decision Date2021-06-24

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