NeoClose 2 AutoAnchor Pack US, NeoClose 4 AutoAnchor Pack US

Laparoscope, General & Plastic Surgery

NEOSURGICAL LTD

The following data is part of a premarket notification filed by Neosurgical Ltd with the FDA for Neoclose 2 Autoanchor Pack Us, Neoclose 4 Autoanchor Pack Us.

Pre-market Notification Details

Device IDK142903
510k NumberK142903
Device Name:NeoClose 2 AutoAnchor Pack US, NeoClose 4 AutoAnchor Pack US
ClassificationLaparoscope, General & Plastic Surgery
Applicant NEOSURGICAL LTD BLOCK 12 GALWAY TECHNOLOGY PARK, PARKMORE Galway,  IE Ei
ContactOria Brennan
CorrespondentOria Brennan
NEOSURGICAL LTD BLOCK 12 GALWAY TECHNOLOGY PARK, PARKMORE Galway,  IE Ei
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-06
Decision Date2014-11-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05391529640569 K142903 000
05391529640231 K142903 000
05391529640200 K142903 000
05391529640170 K142903 000
05391529640132 K142903 000
05391529640118 K142903 000
05391529640095 K142903 000
05391529640071 K142903 000
05391529640026 K142903 000

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