Bluntport Blunt Trocar With Threaded Anchor 5mm-12mm

Laparoscope, General & Plastic Surgery

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Bluntport Blunt Trocar With Threaded Anchor 5mm-12mm.

Pre-market Notification Details

Device IDK142547
510k NumberK142547
Device Name:Bluntport Blunt Trocar With Threaded Anchor 5mm-12mm
ClassificationLaparoscope, General & Plastic Surgery
Applicant COVIDIEN 60 MIDDLETOWN AVE. North Haven,  CT  06473
ContactMary Mellows
CorrespondentMary Mellows
COVIDIEN 60 MIDDLETOWN AVE. North Haven,  CT  06473
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-10
Decision Date2014-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30884521621057 K142547 000
20884521515700 K142547 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.