NEOVEIL Staple Line Reinforcement
K-Number: K221487 · 2022-08-26
ApplicantGunze Limited
Decision Date2022-08-26
Product CodeOXC
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
NEOVEIL Staple Line Reinforcement is a medical device manufactured by Gunze Limited. It received FDA 510(k) clearance on 2022-08-26 under approval number K221487. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NEOVEIL Staple Line Reinforcement?
NEOVEIL Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2022-08-26. It is manufactured by Gunze Limited. The 510(k) number is K221487.
When was NEOVEIL Staple Line Reinforcement approved by the FDA?
NEOVEIL Staple Line Reinforcement received FDA 510(k) clearance on 2022-08-26, under approval number K221487.
What company makes NEOVEIL Staple Line Reinforcement?
NEOVEIL Staple Line Reinforcement is manufactured by Gunze Limited.
What is the FDA product code for NEOVEIL Staple Line Reinforcement?
The FDA product code for NEOVEIL Staple Line Reinforcement is OXC.
Related Clinical Trials
Other Devices by Gunze Limited
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K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLC
K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.
K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.