Cleared Traditional

K050969 - INCLOSE SURGICAL MESH SYSTEM

K050969 is an FDA 510(k) clearance for INCLOSE SURGICAL MESH SYSTEM, manufactured by Anulex Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTL cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K050969 · Anulex Technologies, Inc. · General & Plastic Surgery device
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Aug 2005
Decision
122d
Days
Class 2
Risk

K050969 is an FDA 510(k) clearance for the INCLOSE SURGICAL MESH SYSTEM. Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Anulex Technologies, Inc. (Minnetonka, US). The FDA issued a Cleared decision on August 18, 2005 after a review of 122 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 Anulex Technologies, Inc. devices

FDA 510(k) Submission Details - K050969

510(k) Number K050969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date August 18, 2005
Days to Decision 122 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
7d slower than avg
Panel avg: 115d · This submission: 122d
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 267
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K050969.
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
ORTHOMEND
K051766 · Tei Biosciences, Inc. · Aug 2005
SURGI-WRAP MAST BIORESORBABLE SHEET
K050332 · Mast Biosurgery USA, Inc. · May 2005
MOTIFMESH SOFT TISSUE PATCH
K050678 · Proxy Biomedical , Ltd. · May 2005