NEOVEIL Staple Line Reinforcement— 510(k) K221487

Name: FDA 510(k) clearance K221487
Creator: U.S. Food and Drug Administration
Published: 2022-08-26

Substantially Equivalent

Gunze Limited

FDA 510(k) clearance K221487 for NEOVEIL Staple Line Reinforcement, Substantially Equivalent on 2022-08-26. Applicant: Gunze Limited. Device class: 2.

Clearance details

Applicant: Gunze Limited
Product code: Code OXC
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2022-05-23
Decision date: 2022-08-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Ayabe, Kyoto, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code OXC

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K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)2026-01-09
K231603 — Standard Staple-Line Reinforcement (SSLR23)2023-10-06
K221343 — ECHELON ENDOPATH Staple Line Reinforcement2022-09-16
K190937 — Echelon Endopath Staple Line Reinforcement2019-10-14
K181940 — GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement2018-08-17

More clearances from Gunze Limited

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K213498 — PELNAC Meshed Bilayer Wound Matrix2022-07-14
K213573 — PELNAC Wound Matrix2022-02-09
K191992 — PELNAC Bilayer Wound Matrix2020-04-29
K130997 — NEOVEIL2013-11-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.