Cleared Traditional

K042811 - VIVOSORB SHEET

K042811 is an FDA 510(k) clearance for VIVOSORB SHEET, manufactured by Polyganics B.V.,. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K042811 · Polyganics B.V., · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
27d
Days
Class 2
Risk

K042811 is an FDA 510(k) clearance for the VIVOSORB SHEET, MODEL FS01. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Polyganics B.V., (Groningen, NL). The FDA issued a Cleared decision on November 8, 2004 after a review of 27 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 Polyganics B.V., devices

FDA 510(k) Submission Details - K042811

510(k) Number K042811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date November 08, 2004
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTL Device Classification - Class 2, Special Controls

Product Code FTL Mesh, Surgical, Polymeric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
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 Peers - FTL Mesh, Surgical, Polymeric

All 190
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K042811.
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ULTRAPRO MESH
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