MODIFICATION TO ENDO-EASE

Endoscopic Access Overtube, Gastroenterology-urology

SPIRUS MEDICAL, INC.

The following data is part of a premarket notification filed by Spirus Medical, Inc. with the FDA for Modification To Endo-ease.

Pre-market Notification Details

Device IDK062805
510k NumberK062805
Device Name:MODIFICATION TO ENDO-EASE
ClassificationEndoscopic Access Overtube, Gastroenterology-urology
Applicant SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer,  MA  01432
ContactPamela Papineau
CorrespondentPamela Papineau
SPIRUS MEDICAL, INC. 5 WHITCOMB AVENUE Ayer,  MA  01432
Product CodeFED  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-19
Decision Date2006-10-13
Summary:summary

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