Cleared Traditional

K915774 - PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH

K915774 is an FDA 510(k) clearance for PROLENE POLYPROPYLENE MESH PLUG W/ ONLA..., manufactured by Ethicon, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K915774 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
69d
Days
Class 2
Risk

K915774 is an FDA 510(k) clearance for the PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 69 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.

FDA 510(k) Submission Details - K915774

510(k) Number K915774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date March 02, 1992
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTM Device Classification - Class 2, Special Controls

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 163
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K915774.
PERI-STRIPS
K940205 · Bio-Vascular, Inc. · May 1994
TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER
K922308 · Ti-Mesh, Inc. · Jan 1993
SUPPLE PERI-GUARD
K923657 · Bio-Vascular, Inc. · Dec 1992
COATED NOVAFIL, POLYBUTESTER, MESH
K896946 · American Cyanamid Co. · May 1990
GORE-TEX SURGICAL TAPE
K894580 · W.L. Gore & Associates, Inc. · Oct 1989
NYLAMID MESH PAD FULL & HALF
K852011 · S. Jackson, Inc. · Jun 1985
K915774 · PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
Download PDF FDA Summary Ethicon, Inc.