Cleared Traditional

K150906 - ULTRAPRO ADVANCED Macroporous Particall...

K150906 is an FDA 510(k) clearance for ULTRAPRO ADVANCED Macroporous Particall..., manufactured by Ehicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K150906 · Ehicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
112d
Days
Class 2
Risk

K150906 is an FDA 510(k) clearance for the ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Ehicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 24, 2015 after a review of 112 days - within the typical 510(k) review window.

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 Ehicon, Inc. devices

FDA 510(k) Submission Details - K150906

510(k) Number K150906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2015
Decision Date July 24, 2015
Days to Decision 112 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
3d faster than avg
Panel avg: 115d · This submission: 112d
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 204
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K150906.
Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
K153236 · C.R. Bard, Inc. · May 2016
GORE SYNECOR Biomaterial
K152609 · W.L. Gore & Associates, Inc. · Dec 2015
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH
K143743 · C.R. Bard, Inc. · Sep 2015
Versatex Monofilament Mesh
K150091 · Sofradim Production · May 2015
Modified ONFLEX Mesh
K142706 · C.R. Bard, Inc. · Mar 2015
ONFLEX Mesh
K142711 · C.R. Bard, Inc. · Mar 2015