FiXcision

Surgical Instruments, G-u, Manual (and Accessories)

Agency For Medical Innovations GmbH

The following data is part of a premarket notification filed by Agency For Medical Innovations Gmbh with the FDA for Fixcision.

Pre-market Notification Details

Device IDK182664
510k NumberK182664
Device Name:FiXcision
ClassificationSurgical Instruments, G-u, Manual (and Accessories)
Applicant Agency For Medical Innovations GmbH Im Letten 1 Feldkirch,  AT 6800
ContactMartin Hohlrieder
CorrespondentAllison C. Komiyama
AcKnowledge Regulatory Strategies, LLC 2251 San Diego Ave., Suite B-257 San Diego,  CA  92110
Product CodeKOA  
CFR Regulation Number876.4730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-25
Decision Date2018-12-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
EAMIFIX20011 K182664 000

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