CleverLock Guidewire Locking Device And Biopsy Cap

Endoscope Channel Accessory

Olympus Surgical Technologies America

The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Cleverlock Guidewire Locking Device And Biopsy Cap.

Pre-market Notification Details

Device IDK190164
510k NumberK190164
Device Name:CleverLock Guidewire Locking Device And Biopsy Cap
ClassificationEndoscope Channel Accessory
Applicant Olympus Surgical Technologies America 136 Turnpike Road Southborough,  MA  01772 -2104
ContactMary Anne Patella
CorrespondentMary Anne Patella
Olympus Surgical Technologies America 136 Turnpike Road Southborough,  MA  01772 -2104
Product CodeODC  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-31
Decision Date2019-04-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925043343 K190164 000

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