Cleared Abbreviated

K171039 - Assut Filbloc Permanent Sutures

K171039 is an FDA 510(k) clearance for Assut Filbloc Permanent Sutures, manufactured by Assut Europe S.P.A.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Abbreviated 510(k) pathway after a 145-day FDA review.

K171039 · Assut Europe S.P.A. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
145d
Days
Class 2
Risk

K171039 is an FDA 510(k) clearance for the Assut Filbloc Permanent Sutures. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Assut Europe S.P.A. (Magliano Dei Marsi, IT). The FDA issued a Cleared decision on August 29, 2017 after a review of 145 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - the FDA general and plastic surgery device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K171039

510(k) Number K171039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2017
Decision Date August 29, 2017
Days to Decision 145 days
Submission Type Abbreviated
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
30d slower than avg
Panel avg: 115d · This submission: 145d
Pathway characteristics
Standards-based clearance path.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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.

Regulatory Consultant

Donawa Lifescience Consulting Srl
Roger Gray

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 80
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K171039.
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