Cleared Traditional

K121776 - AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE

K121776 is an FDA 510(k) clearance for AGILITY STEERABLE GUIDEWIRE NEUROSCOUT ..., manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K121776 · Codman & Shurtleff, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
57d
Days
Class 2
Risk

K121776 is an FDA 510(k) clearance for the AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on August 14, 2012 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 - K121776

510(k) Number K121776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2012
Decision Date August 14, 2012
Days to Decision 57 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
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 755
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K121776.
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K113162 · Acme-Monaco Corp. · Jul 2012
DISPOSABLE TORQUE DEVICE
K113498 · Coeur, Inc. · Jul 2012
MANTARAY GUIDEWIRES
K121745 · Bridgepoint Medical · Jul 2012
K121776 · AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
Download PDF FDA Summary Codman & Shurtleff, I…