Cleared Traditional

K905287 - IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES

K905287 is an FDA 510(k) clearance for IFSA STERILE SILK BRAIDED NONABSOR SURG..., manufactured by Internacional Farmaceutica, S.A. DE C.V.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K905287 · 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

K905287 is an FDA 510(k) clearance for the IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES. Classified as Suture, Nonabsorbable, Silk (product code GAP), 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 878.5030 - 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 - K905287

510(k) Number K905287 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.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 19
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K905287.
SOFSILK
K964581 · United States Surgical, A Division of Tyco Healthc · Jan 1997
SUTURES POLYPROP., POLYETHELINE, NYLON & SILK
K930739 · Deknatel, Inc. · Jul 1994
VISITEC PRECISE-POINT
K942234 · Visitec Co. · Jul 1994
NONABSORBABLE SILK SURGICAL SUTURE
K904478 · United States Surgical, A Division of Tyco Healthc · Nov 1990
NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE)
K904891 · United States Surgical, A Division of Tyco Healthc · Nov 1990
AIRWAY PRESSURE MONITOR
K761199 · Draeger Medical, Inc. · Feb 1977