GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER

Dilator, Catheter, Ureteral

OLYMPUS SURGICAL TECHNOLOGIES AMERICA

The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Gyrus Acmi Uro-ezdilate Ureteral Balloon Dilation Catheter.

Pre-market Notification Details

Device IDK132181
510k NumberK132181
Device Name:GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
ClassificationDilator, Catheter, Ureteral
Applicant OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough,  MA  01772
ContactNeil Kelly
CorrespondentNeil Kelly
OLYMPUS SURGICAL TECHNOLOGIES AMERICA 136 TURNPIKE ROAD Southborough,  MA  01772
Product CodeEZN  
CFR Regulation Number876.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-15
Decision Date2013-10-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925033153 K132181 000
00821925033054 K132181 000
00821925033061 K132181 000
00821925033078 K132181 000
00821925033085 K132181 000
00821925033092 K132181 000
00821925033108 K132181 000
00821925033115 K132181 000
00821925033122 K132181 000
00821925033139 K132181 000
00821925033146 K132181 000
00821925033047 K132181 000

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