Cleared Traditional

K905285 - IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES

K905285 is an FDA 510(k) clearance for IFSA STERILE BRAIDED POLY NONABSOR SURG..., manufactured by Internacional Farmaceutica, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAS cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K905285 · Internacional Farmaceutica, S.A. DE C.V. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1991
Decision
77d
Days
Class 2
Risk

K905285 is an FDA 510(k) clearance for the IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polyester (product code GAS), 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 878.5000 - 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 - K905285

510(k) Number K905285 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
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.

GAS Device Classification - Class 2, Special Controls

Product Code GAS Suture, Nonabsorbable, Synthetic, Polyester
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAS Suture, Nonabsorbable, Synthetic, Polyester

All 11
Devices cleared under the same product code (GAS) and FDA review panel - the closest regulatory comparables to K905285.
BRAIDED POLYESTER SUTURE MATERIAL
K923161 · Mitek Surgical Products, Inc. · Dec 1992
MITEK QUICKANCHOR(TM), MODIFICATION
K915089 · Mitek Surgical Products, Inc. · Feb 1992
MITEK SNAP PAK(TM), MODIFICATION
K915081 · Mitek Surgical Products, Inc. · Jan 1992
FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE
K905440 · United States Surgical, A Division of Tyco Healthc · Jan 1991
QUICKANCHOR (TM)
K904436 · Mitek Surgical Products, Inc. · Dec 1990
POLYVIOLENE(TM) SUTURE
K904054 · Look, Inc. · Oct 1990