Cleared Traditional

K043191 - REPOL ANGIMESH

K043191 is an FDA 510(k) clearance for REPOL ANGIMESH, manufactured by Angiologica B. M. Srl. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K043191 · Angiologica B. M. Srl · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
180d
Days
Class 2
Risk

K043191 is an FDA 510(k) clearance for the REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, .... Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Angiologica B. M. Srl (San Martino Siccomario, Pavia, IT). The FDA issued a Cleared decision on May 16, 2005 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Angiologica B. M. Srl devices

FDA 510(k) Submission Details - K043191

510(k) Number K043191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2004
Decision Date May 16, 2005
Days to Decision 180 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
65d slower than avg
Panel avg: 115d · This submission: 180d
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 K043191.
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K053200 · W.L. Gore & Associates, Inc. · Dec 2005
BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED
K052155 · C.R. Bard, Inc. · Oct 2005
VICRYL * MESH BAG
K051701 · Ethicon, Inc. · Sep 2005
PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES
K050187 · Sofradim Production · Feb 2005
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K043056 · W.L. Gore & Associates, Inc. · Dec 2004
GORE POLYPROPYLENE HERNIA MESH
K043081 · W.L. Gore & Associates, Inc. · Dec 2004