Cleared Traditional

K083049 - TORNADO ROTATABEL SNARE AND POLYP CATCHER

K083049 is an FDA 510(k) clearance for TORNADO ROTATABEL SNARE AND POLYP CATCHER, manufactured by Horizons Intl. Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K083049 · Horizons Intl. Corp. · Gastroenterology & Urology device
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Dec 2008
Decision
70d
Days
Class 2
Risk

K083049 is an FDA 510(k) clearance for the TORNADO ROTATABEL SNARE AND POLYP CATCHER. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Horizons Intl. Corp. (Barreal De Heredia, CR). The FDA issued a Cleared decision on December 23, 2008 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4300 - the FDA gastroenterology and urology 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 Horizons Intl. Corp. devices

FDA 510(k) Submission Details - K083049

510(k) Number K083049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2008
Decision Date December 23, 2008
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDI Device Classification - Class 2, Special Controls

Product Code FDI Snare, Flexible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4300
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDI Snare, Flexible

All 44
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K083049.
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