Cleared Traditional

K905286 - IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES

K905286 is an FDA 510(k) clearance for IFSA STERILE NLYLON MONOFIL NONABSOR SU..., manufactured by Internacional Farmaceutica, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K905286 · Internacional Farmaceutica, S.A. DE C.V. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1991
Decision
77d
Days
Class 2
Risk

K905286 is an FDA 510(k) clearance for the IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Internacional Farmaceutica, S.A. DE C.V. (Great Neck, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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 - K905286

510(k) Number K905286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1990
Decision Date February 11, 1991
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K905286.
PETERS CARDIONYL(TM) SUTURE
K913102 · Promedica Products, Inc. · Aug 1992
N80-838 SUPRAMID EXTRA SUTURE
K912429 · S. Jackson, Inc. · Oct 1991
ADVANCE SUTURE NONABSORBABLE NYLON SUTURE
K903177 · Advance Suture, Inc. · Jun 1991
AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER*
K904931 · United States Surgical, A Division of Tyco Healthc · Jan 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · United States Surgical, A Division of Tyco Healthc · Jan 1991
STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE
K903029 · Look, Inc. · Oct 1990
K905286 · IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES
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