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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Gunze Limited. It received FDA 510(k) clearance on 2022-08-26 under 510(k) 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. The listed applicant is Gunze Limited. The 510(k) number is K221487.

When did NEOVEIL Staple Line Reinforcement receive FDA 510(k) clearance?

NEOVEIL Staple Line Reinforcement received FDA 510(k) clearance on 2022-08-26, under 510(k) number K221487.

Who is the listed applicant for NEOVEIL Staple Line Reinforcement?

The FDA 510(k) record lists Gunze Limited as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07339020Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve GastrectomyCOMPLETED

Other records listing Gunze Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213498PELNAC Meshed Bilayer Wound MatrixK213573PELNAC Wound MatrixK191992PELNAC Bilayer Wound Matrix

Related Devices (Code: OXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLCK231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.K221343ECHELON ENDOPATH Staple Line ReinforcementEthicon Endo-Surgery, LLCK190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLCK181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.

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.

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