RE-TRACE URETERAL ACCESS SHEATH

Endoscopic Access Overtube, Gastroenterology-urology

COLOPLAST A/S

The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Re-trace Ureteral Access Sheath.

Pre-market Notification Details

Device IDK102485
510k NumberK102485
Device Name:RE-TRACE URETERAL ACCESS SHEATH
ClassificationEndoscopic Access Overtube, Gastroenterology-urology
Applicant COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
ContactBrian Schmidt
CorrespondentBrian Schmidt
COLOPLAST A/S 1601 WEST RIVER ROAD N Minneapolis,  MN  55411
Product CodeFED  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-30
Decision Date2010-10-18
Summary:summary

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