Cleared Traditional

K010936 - MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

K010936 is an FDA 510(k) clearance for MODIFICATION TO SEAMGUARD STAPLE LINE R..., manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OXD cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K010936 · W.L. Gore & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
54d
Days
Class 2
Risk

K010936 is an FDA 510(k) clearance for the MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL. Classified as Mesh, Surgical, Non-absorbable, Staple Line Reinforcement (product code OXD), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on May 21, 2001 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K010936

510(k) Number K010936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date May 21, 2001
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXD Device Classification - Class 2, Special Controls

Product Code OXD Mesh, Surgical, Non-absorbable, Staple Line Reinforcement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.