Cleared Traditional

K012724 - SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE ...

K012724 is the FDA 510(k) clearance for SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE ... by Smith & Nephew, Inc.. It is a Class 2 Cardiovascular device (product code LYK) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K012724 · Smith & Nephew, Inc. · Cardiovascular device
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Nov 2001
Decision
86d
Days
Class 2
Risk

K012724 is an FDA 510(k) clearance for the SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273. Classified as Angioscope (product code LYK), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on November 8, 2001 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 876.1500 - 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.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K012724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2001
Decision Date November 08, 2001
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYK Angioscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - LYK Angioscope

All 19
Devices cleared under the same product code (LYK) and FDA review panel - the closest regulatory comparables to K012724.
Vena MicroAngioscope™ System
K253842 · Vena Medical Holdings Corp · Jan 2026
Vena MicroAngioscope™ System
K251767 · Vena Medical Holdings Corp · Oct 2025
KSEA FIBERSCOPE
K011793 · KARL STORZ Endoscopy-America, Inc. · Apr 2002
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)
K964061 · W.L. Gore & Associates, Inc. · Feb 1997
APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE
K951721 · Applied Medical Resources · Jul 1995