APOLLO SYSTEM

Endoscope, Neurological

PENUMBRA, INC.

The following data is part of a premarket notification filed by Penumbra, Inc. with the FDA for Apollo System.

Pre-market Notification Details

Device IDK132931
510k NumberK132931
Device Name:APOLLO SYSTEM
ClassificationEndoscope, Neurological
Applicant PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
ContactSeth Schulman
CorrespondentSeth Schulman
PENUMBRA, INC. 1351 HARBOR BAY PARKWAY Alameda,  CA  94502
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-18
Decision Date2014-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814548017563 K132931 000
00814548012711 K132931 000
00814548012728 K132931 000
00814548013589 K132931 000
00814548013596 K132931 000
00814548013602 K132931 000
00814548013619 K132931 000
00814548016344 K132931 000
00814548016351 K132931 000
00814548016368 K132931 000
00814548016375 K132931 000
00814548016382 K132931 000
00814548016474 K132931 000
00814548012704 K132931 000

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