Cleared Traditional

K896946 - COATED NOVAFIL, POLYBUTESTER, MESH

K896946 is an FDA 510(k) clearance for COATED NOVAFIL, manufactured by American Cyanamid Co.. The device is a Class 2 General & Plastic Surgery device with product code FTM cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K896946 · American Cyanamid Co. · General & Plastic Surgery device
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May 1990
Decision
145d
Days
Class 2
Risk

K896946 is an FDA 510(k) clearance for the COATED NOVAFIL, POLYBUTESTER, MESH. Classified as Mesh, Surgical (product code FTM), Class II - Special Controls.

Submitted by American Cyanamid Co. (Danbury, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 145 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 American Cyanamid Co. devices

FDA 510(k) Submission Details - K896946

510(k) Number K896946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1989
Decision Date May 07, 1990
Days to Decision 145 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 115d · This submission: 145d
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 147
Devices cleared under the same product code (FTM) and FDA review panel - the closest regulatory comparables to K896946.
PERI-STRIPS
K940205 · Bio-Vascular, Inc. · May 1994
SUPPLE PERI-GUARD
K923657 · Bio-Vascular, Inc. · Dec 1992
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
PDS POLYDIOXANONE MESH
K844228 · Ethicon, Inc. · Jan 1985