AirSeal® DV Solution- AirSeal® Cannula Cap And AirSeal® Bifurcated Filtered Tube Set

Insufflator, Laparoscopic

ConMed Corporation

The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Airseal® Dv Solution- Airseal® Cannula Cap And Airseal® Bifurcated Filtered Tube Set.

Pre-market Notification Details

Device IDK211104
510k NumberK211104
Device Name:AirSeal® DV Solution- AirSeal® Cannula Cap And AirSeal® Bifurcated Filtered Tube Set
ClassificationInsufflator, Laparoscopic
Applicant ConMed Corporation 525 French Road Utica,  NY  13502
ContactAlly Xu
CorrespondentAlly Xu
ConMed Corporation 525 French Road Utica,  NY  13502
Product CodeHIF  
CFR Regulation Number884.1730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-13
Decision Date2021-08-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854051402 K211104 000
20845854051396 K211104 000

Trademark Results [AirSeal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AIRSEAL
AIRSEAL
88148364 5773913 Live/Registered
Sto Corp.
2018-10-09
AIRSEAL
AIRSEAL
86586886 not registered Dead/Abandoned
Sealco LLC
2015-04-03
AIRSEAL
AIRSEAL
85684858 4356862 Live/Registered
Polymer Adhesives Sealant Systems, Inc.
2012-07-23
AIRSEAL
AIRSEAL
85684857 4356861 Live/Registered
Polymer Adhesives Sealant Systems, Inc.
2012-07-23
AIRSEAL
AIRSEAL
78928299 3652736 Live/Registered
SurgiQuest, Inc.
2006-07-12
AIRSEAL
AIRSEAL
77763034 3739787 Dead/Cancelled
ASI DOORS, INC.
2009-06-18
AIRSEAL
AIRSEAL
77724885 3713580 Live/Registered
Sealco, Inc.
2009-04-29
AIRSEAL
AIRSEAL
76258662 2730878 Dead/Cancelled
ASI Technologies, Inc.
2001-05-16
AIRSEAL
AIRSEAL
76011088 2545388 Dead/Cancelled
Polymer Adhesives Sealant Systems, Inc.
2000-03-27
AIRSEAL
AIRSEAL
74636411 not registered Dead/Abandoned
SPORTS-MITT INTERNATIONAL
1995-02-21
AIRSEAL
AIRSEAL
74526209 1896101 Live/Registered
SIGNIFY NORTH AMERICA CORPORATION
1994-05-18
AIRSEAL
AIRSEAL
74399827 1824347 Dead/Cancelled
Delta Cycle Corporation
1993-06-04

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