SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE

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 Spirus Medical Endo-ease Endoscopic Overtube.

Pre-market Notification Details

Device IDK080050
510k NumberK080050
Device Name:SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-01-08
Decision Date2008-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00867630000226 K080050 000
00867630000219 K080050 000
00867630000202 K080050 000

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