Nuvis Battery Arthroscope

Arthroscope

Integrated Endoscopy, Inc.

The following data is part of a premarket notification filed by Integrated Endoscopy, Inc. with the FDA for Nuvis Battery Arthroscope.

Pre-market Notification Details

Device IDK191594
510k NumberK191594
Device Name:Nuvis Battery Arthroscope
ClassificationArthroscope
Applicant Integrated Endoscopy, Inc. 16 Technology Drive, Suite 165 Irvine,  CA  92618
ContactAlbert Rego
CorrespondentAlbert Rego
Integrated Endoscopy, Inc. 16 Technology Drive, Suite 165 Irvine,  CA  92618
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-17
Decision Date2019-07-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10853816008008 K191594 000
00853816008001 K191594 000

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