FlexSys

Powered Laser Surgical Instrument

GME German Medical Engineering GmbH

The following data is part of a premarket notification filed by Gme German Medical Engineering Gmbh with the FDA for Flexsys.

Pre-market Notification Details

Device IDK203054
510k NumberK203054
Device Name:FlexSys
ClassificationPowered Laser Surgical Instrument
Applicant GME German Medical Engineering GmbH Dreikoenigstrasse 6-8 Erlangen,  DE 91054
ContactStefan Schulze
CorrespondentKatja Kerl
Philosopher's River LLC Dreikoenigstrasse 6-8 Erlangen,  DE 91054
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-07
Decision Date2021-03-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B12510700 K203054 000

Trademark Results [FlexSys]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEXSYS
FLEXSYS
90884964 not registered Live/Pending
FLEXSYS, INC.
2021-08-16
FLEXSYS
FLEXSYS
90851472 not registered Live/Pending
Multistack, LLC
2021-07-27
FLEXSYS
FLEXSYS
85033243 3893840 Dead/Cancelled
Multistack LLC
2010-05-07
FLEXSYS
FLEXSYS
78356899 2985169 Dead/Cancelled
Flexsys America, L.P.
2004-01-23
FLEXSYS
FLEXSYS
78356892 2985168 Dead/Cancelled
Flexsys America, L.P.
2004-01-23
FLEXSYS
FLEXSYS
78143931 2887525 Live/Registered
ATS Automation Tooling Systems Inc.
2002-07-15
FLEXSYS
FLEXSYS
78095931 not registered Dead/Abandoned
DataCard Corporation
2001-11-30
FLEXSYS
FLEXSYS
77921449 3872487 Dead/Cancelled
Flexsys America, L.P.
2010-01-27
FLEXSYS
FLEXSYS
77535721 3800230 Dead/Cancelled
Flexsys America, L.P.
2008-07-31
FLEXSYS
FLEXSYS
76573026 not registered Indifferent
Flexsys America, L.P.
0000-00-00
FLEXSYS
FLEXSYS
76438228 not registered Dead/Abandoned
Bio-Rad Laboratories, Inc.
2002-08-05
FLEXSYS
FLEXSYS
76312026 not registered Dead/Abandoned
Foundation of Flexographic Technical Association
2001-09-17
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