Cleared Traditional

K911189 - STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE

K911189 is an FDA 510(k) clearance for STERILE POLYPROPYLENE MONFIL NONABSORB ..., manufactured by Internacional Farmaceutica, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K911189 · Internacional Farmaceutica, S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
38d
Days
Class 2
Risk

K911189 is an FDA 510(k) clearance for the STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Internacional Farmaceutica, S.A. DE C.V. (Great Neck, US). The FDA issued a Cleared decision on April 25, 1991 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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 Internacional Farmaceutica, S.A. DE C.V. devices

FDA 510(k) Submission Details - K911189

510(k) Number K911189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1991
Decision Date April 25, 1991
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 44
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K911189.
MOPYLEN SUTURE
K931614 · S. Jackson, Inc. · Dec 1993
SYNTHETIC ABSORBABLE SUTURE, UNDYED
K920437 · Ethicon, Inc. · Jul 1992
DEKNATEL(R) MICROFLEX OPHTHAL POLY SUTURE,MODIFIED
K911905 · Deknatel, Inc. · Jul 1991
DEKNATEL MICROFLEX OPHTHALMIC POLYPROPYLENE SUTURE
K903643 · Deknatel, Inc. · Dec 1990
POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
K903584 · Look, Inc. · Oct 1990
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
K902872 · United States Surgical, A Division of Tyco Healthc · Sep 1990