Biodesign Staple Line Reinforcement

FDA 510(k) K170945 · Cook Biotech Incorporated

Substantially Equivalent

510(k) numberK170945

Submission

Device name
Biodesign Staple Line Reinforcement
Applicant
Cook Biotech Incorporated
West Lafayette, IN, US
Received
March 30, 2017
Decision date
April 28, 2017
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OXE – Mesh, Surgical, Collagen, Staple Line Reinforcement
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.

Other 510(k)s with product code OXE

510(k)DeviceApplicantDecision
K153364Kerecis SecureMeshOXE · Traditional Kerecis Limited08/19/2016SE
K030879Veritas Collagen MatrixOXE · Traditional Synovis Surgical Innovations04/24/2003SE
K022044Surgisis Staple Line ReinforcementOXE · Traditional Cook Biotech, Inc.08/23/2002SE

More from Cook Biotech, Inc.

510(k)DeviceDecision
K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…KHJ · Traditional 05/24/2024SE
K201000Biodesign Staple Line ReinforcementFTM · Traditional 07/13/2020SE
K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…OXN · Traditional 12/27/2019SE
K171817Biodesign Diaphragmatic Hernia GraftFTM · Traditional 03/13/2018SE
K162934Biodesign Parastomal Hernia Repair GraftFTM · Traditional 07/10/2017SE
K170016Biodesign Fistula PlugFTM · Traditional 06/21/2017SE
K161762DynaMatrix/Dynamatrix PlusNPL · Special 01/13/2017SE
K162741AxoGuard Nerve ConnectorJXI · Special 10/31/2016SE
K160136Flowable Wound MatrixKGN · Traditional 09/28/2016SE
K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugFTM · Special 05/26/2016SE

Questions and answers

When was Biodesign Staple Line Reinforcement cleared by the FDA?

Biodesign Staple Line Reinforcement (K170945) received a 510(k) decision of Substantially Equivalent on April 28, 2017, 29 days after the submission was received.

What is the product code of K170945?

The FDA product code is OXE – Mesh, Surgical, Collagen, Staple Line Reinforcement, a Class II (moderate risk) device regulated under 21 CFR 878.3300.