Cleared Special

NEOVEIL Staple Line Reinforcement

K221487 · Gunze Limited · General & Plastic Surgery

Aug 2022

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K221487 is an FDA 510(k) clearance for the NEOVEIL Staple Line Reinforcement, a Mesh, Surgical, Absorbable, Staple Line Reinforcement (Class II — Special Controls, product code OXC), submitted by Gunze Limited (Ayabe, Kyoto, JP). The FDA issued a Cleared decision on August 26, 2022, 95 days after receiving the submission on May 23, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K221487 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2022
Decision Date	August 26, 2022
Days to Decision	95 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OXC — Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3300
Definition	For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.