SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 Or Packaged With Kit)

Snare, Flexible

Steris Corporation

The following data is part of a premarket notification filed by Steris Corporation with the FDA for Smartband Emr Kit (sb-emr-k, Sb-emr-k-12, Sb-emr-k-9.4), Smartband Emr Pack (sb-emr-p, Sb-emr-p-12, Sb-emr-p-9.4), Smartsnare Emr Hexagonal Snare (ss-230-1 Or Packaged With Kit).

Pre-market Notification Details

Device IDK212860
510k NumberK212860
Device Name:SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 Or Packaged With Kit)
ClassificationSnare, Flexible
Applicant Steris Corporation 5976 Heisley Road Mentor,  OH  44060
ContactCarroll Martin
CorrespondentCarroll Martin
Steris Corporation 5976 Heisley Road Mentor,  OH  44060
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-08
Decision Date2021-10-07

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