Cleared Traditional

K844228 - PDS POLYDIOXANONE MESH

K844228 is the FDA 510(k) clearance for PDS POLYDIOXANONE MESH by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K844228 · Ethicon, Inc. · General & Plastic Surgery device
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Jan 1985
Decision
84d
Days
Class 2
Risk

K844228 is an FDA 510(k) clearance for the PDS POLYDIOXANONE MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on January 24, 1985 after a review of 84 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 Ethicon, Inc. devices

Submission Details

510(k) Number K844228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1984
Decision Date January 24, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FTM Mesh, Surgical
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 - FTM Mesh, Surgical

All 44
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K844228.
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
K915774 · Ethicon, Inc. · Mar 1992
GORE-TEX SURGICAL TAPE
K894580 · W.L. Gore & Associates, Inc. · Oct 1989
VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH
K851086 · Ethicon, Inc. · May 1985
LINK ACETABULAR MESH
K844225 · Waldemar Link GmbH & Co. KG · Nov 1984
DEXON 'S' POLYGLYCOLIC ACID MESH
K830889 · Davis & Geck, Inc. · May 1983