Cleared Traditional

SURGISIS STAPLE LINE REINFORCEMENT

K022044 · Cook Biotech, Inc. · General & Plastic Surgery

Aug 2002

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K022044 is an FDA 510(k) clearance for the SURGISIS STAPLE LINE REINFORCEMENT, a Mesh, Surgical, Collagen, Staple Line Reinforcement (Class II — Special Controls, product code OXE), submitted by Cook Biotech, Inc. (West Lafayette, US). The FDA issued a Cleared decision on August 23, 2002, 60 days after receiving the submission on June 24, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K022044 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 2002
Decision Date	August 23, 2002
Days to Decision	60 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OXE — Mesh, Surgical, Collagen, 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.