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510(k) K181940

Device
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
Applicant
W. L. Gore & Associates, Inc.
510(k) number
K181940
Product code
OXC  
Decision
Substantially Equivalent (SESE)
Decision date
2018-08-17
Date received
2018-07-19
Regulation
878.3300
Classification name
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michael J. Titus
Address
301 Airport Rd. Elkton MD US 21922 21922

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OXC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC2026-01-09
K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.2023-10-06
K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC2022-09-16
K221487NEOVEIL Staple Line ReinforcementGunze Limited2022-08-26
K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC2019-10-14
K150551GORE SEAMGUARD ReinforcementW. L. Gore & Associates, Inc.2015-03-30
K130997NEOVEILGunze Limited2013-11-15
K131658GORE SEAMGUARD REINFORCEMENTW. L. Gore & Associates, Inc.2013-09-06

Legacy Summary#

summary

FDA Review#

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