Cleared Traditional

K023411 - STEELEX STERNUM SET

K023411 is an FDA 510(k) clearance for STEELEX STERNUM SET, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K023411 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
69d
Days
Class 2
Risk

K023411 is an FDA 510(k) clearance for the STEELEX STERNUM SET. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 19, 2002 after a review of 69 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.

FDA 510(k) Submission Details - K023411

510(k) Number K023411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2002
Decision Date December 19, 2002
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
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 31
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K023411.
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
K032468 · Suturtek Incorporated · Sep 2003
TENO FIX
K023594 · Ortheon Medical, LLC · May 2003
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351 · Cp Medical · Mar 2003
MANUAL TOUCHE SYSTEM
K022777 · Onux Medical, Inc. · Nov 2002
STONY BROOK SURGICAL INNOVAIONS STERNA-WIRE (STERNAL SUTURES)
K013059 · Stony Brook Surgical Innovations, Inc. · Oct 2001
ACIER SUTURES
K991073 · Cardio Thoracic Systems · Jul 1999
K023411 · STEELEX STERNUM SET
Download PDF FDA Summary Aesculap, Inc.