Cleared Traditional

K040001 - STEERABLE STYLET

K040001 is an FDA 510(k) clearance for STEERABLE STYLET, manufactured by Synovis Surgical Innovations. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K040001 · Synovis Surgical Innovations · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
67d
Days
Class 2
Risk

K040001 is an FDA 510(k) clearance for the STEERABLE STYLET. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on March 9, 2004 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - the FDA cardiovascular device oversight 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 - K040001

510(k) Number K040001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2004
Decision Date March 09, 2004
Days to Decision 67 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRB Device Classification - Class 2, Special Controls

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRB Stylet, Catheter

All 26
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K040001.
ACUITY STEERABLE STYLET ACCESSORY
K053019 · Guidant Corporation · Mar 2006
EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.
K052965 · Guidant Corporation · Feb 2006
SPECTRANETICS LLD CS, MODEL 518-039
K043401 · Spectranetics Corp. · Mar 2005
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
EUPALAMUS DEFLECTABLE STYLET, MODEL 01545
K002534 · Eupalamus, LLC · Oct 2000
K040001 · STEERABLE STYLET
Download PDF FDA Summary Synovis Surgical Inno…