Cleared Traditional

K192389 - TYRX Absorbable Antibacterial Envelope ...

K192389 is the FDA 510(k) clearance for TYRX Absorbable Antibacterial Envelope ... by Medtronic, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTL) cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K192389 · Medtronic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
206d
Days
Class 2
Risk

K192389 is an FDA 510(k) clearance for the TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacteria.... Classified as Mesh, Surgical, Polymeric (product code FTL), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on March 27, 2020 after a review of 206 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 Medtronic, Inc. devices

Submission Details

510(k) Number K192389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date March 27, 2020
Days to Decision 206 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 115d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 185
Devices cleared under the same product code (FTL) and FDA review panel - the closest regulatory comparables to K192389.
3DMax MID Anatomical Mesh
K200818 · C.R. Bard, Inc. · Jul 2020
TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
K192636 · Medtronic, Inc. · Apr 2020
T-Line Hernia Mesh
K193144 · Deep Blue Medical Advances, Inc. · Mar 2020
Dextile Anatomical Mesh
K192443 · Sofradim Production · Dec 2019
VICRYL Mesh
K191373 · Ethicon, Inc. · Oct 2019
FlexBand Plus
K192112 · International Life Sciences · Sep 2019