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FDA 510(k)

NEOVEIL

K-Number: K130997 · 2013-11-15

ApplicantGunze Limited
Decision Date2013-11-15
Product CodeOXC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEOVEIL is the device name listed in this FDA 510(k) record. The listed applicant is Gunze Limited. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K130997. 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?

NEOVEIL is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Gunze Limited. The 510(k) number is K130997.

When did NEOVEIL receive FDA 510(k) clearance?

NEOVEIL received FDA 510(k) clearance on 2013-11-15, under 510(k) number K130997.

Who is the listed applicant for NEOVEIL?

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?

The FDA product code for NEOVEIL 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.

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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.

K221487NEOVEIL Staple Line ReinforcementK213498PELNAC 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, LLCK221487NEOVEIL Staple Line ReinforcementGunze LimitedK190937Echelon 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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