NEOVEIL Staple Line Reinforcement

FDA 510(k) K221487 · Gunze Limited

Substantially Equivalent

510(k) numberK221487

Submission

Device name
NEOVEIL Staple Line Reinforcement
Applicant
Gunze Limited
Ayabe, Kyoto, JP
Received
May 23, 2022
Decision date
August 26, 2022
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OXC – Mesh, Surgical, Absorbable, 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 OXC

510(k)DeviceApplicantDecision
K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)OXC · Traditional Ethicon Endo-Surgery, LLC01/09/2026SE
K231603Standard Staple-Line Reinforcement (SSLR23)OXC · Traditional Standard Bariatrics, Inc.10/06/2023SE
K221343ECHELON ENDOPATH Staple Line ReinforcementOXC · Traditional Ethicon Endo-Surgery, LLC09/16/2022SE
K190937Echelon Endopath Staple Line ReinforcementOXC · Traditional Ethicon Endo-Surgery, LLC10/14/2019SE
K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special W. L. Gore & Associates, Inc.08/17/2018SE
K150551GORE SEAMGUARD ReinforcementOXC · Special W. L. Gore & Associates, Inc.03/30/2015SE
K130997NeoveilOXC · Traditional Gunze Limited11/15/2013SE
K131658Gore Seamguard ReinforcementOXC · Traditional W. L. Gore & Associates, Inc.09/06/2013SE

More from W. L. Gore & Associates, Inc.

510(k)DeviceDecision
K213498PELNAC Meshed Bilayer Wound MatrixKGN · Traditional 07/14/2022SE
K213573PELNAC Wound MatrixKGN · Traditional 02/09/2022SE
K191992PELNAC Bilayer Wound MatrixKGN · Traditional 04/29/2020SE
K130997NeoveilOXC · Traditional 11/15/2013SE

Questions and answers

When was NEOVEIL Staple Line Reinforcement cleared by the FDA?

NEOVEIL Staple Line Reinforcement (K221487) received a 510(k) decision of Substantially Equivalent on August 26, 2022, 95 days after the submission was received.

What is the product code of K221487?

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