CUSA NXT EXTENDED LENGTH TIP

Instrument, Ultrasonic Surgical

INTEGRA RADIONICS, INC.

The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Cusa Nxt Extended Length Tip.

Pre-market Notification Details

Device IDK102258
510k NumberK102258
Device Name:CUSA NXT EXTENDED LENGTH TIP
ClassificationInstrument, Ultrasonic Surgical
Applicant INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
ContactKevin J O'connell
CorrespondentKevin J O'connell
INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-10
Decision Date2011-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10381780039518 K102258 000

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