Cleared Traditional

K851086 - VICRYL (POLYGLACTIN 910/MERSILENE COMPO...

K851086 is the FDA 510(k) clearance for VICRYL (POLYGLACTIN 910/MERSILENE COMPO... by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code FTM) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K851086 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
64d
Days
Class 2
Risk

K851086 is an FDA 510(k) clearance for the VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE 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 May 21, 1985 after a review of 64 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 K851086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1985
Decision Date May 21, 1985
Days to Decision 64 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
51d faster than avg
Panel avg: 115d · This submission: 64d
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 K851086.
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330 · Depuy, Inc. · Sep 1998
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
K915774 · Ethicon, Inc. · Mar 1992
GORE-TEX SURGICAL TAPE
K894580 · W.L. Gore & Associates, Inc. · Oct 1989
PDS POLYDIOXANONE MESH
K844228 · Ethicon, Inc. · Jan 1985
LINK ACETABULAR MESH
K844225 · Waldemar Link GmbH & Co. KG · Nov 1984
DEXON 'S' POLYGLYCOLIC ACID MESH
K830889 · Davis & Geck, Inc. · May 1983