Cleared Traditional

K013059 - STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)

K013059 is an FDA 510(k) clearance for STONY BROOK SURGICAL INNOVAIONS STERNA-..., manufactured by Stony Brook Surgical Innovations, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K013059 · Stony Brook Surgical Innovations, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
41d
Days
Class 2
Risk

K013059 is an FDA 510(k) clearance for the STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES). Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Stony Brook Surgical Innovations, Inc. (Great Neck, US). The FDA issued a Cleared decision on October 22, 2001 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - 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 Stony Brook Surgical Innovations, Inc. devices

FDA 510(k) Submission Details - K013059

510(k) Number K013059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2001
Decision Date October 22, 2001
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAQ Device Classification - Class 2, Special Controls

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
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 - GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

All 19
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K013059.
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa) · Aug 2004
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351 · Cp Medical · Mar 2003
STEELEX STERNUM SET
K023411 · Aesculap, Inc. · Dec 2002
ACIER SUTURES
K991073 · Cardio Thoracic Systems · Jul 1999
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
K984151 · Mill Pond, Inc. · Apr 1999
STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)
K955723 · Davis & Geck, Inc. · Feb 1996