Cleared Traditional

K011667 - HORIZONS INTERNATIONAL POLYPECTOMY SNARES

K011667 is an FDA 510(k) clearance for HORIZONS INTERNATIONAL POLYPECTOMY SNARES, 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 78-day FDA review.

K011667 · Horizons Intl. Corp. · Gastroenterology & Urology device
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Aug 2001
Decision
78d
Days
Class 2
Risk

K011667 is an FDA 510(k) clearance for the HORIZONS INTERNATIONAL POLYPECTOMY SNARES. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Horizons Intl. Corp. (Ponce, US). The FDA issued a Cleared decision on August 16, 2001 after a review of 78 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 - K011667

510(k) Number K011667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2001
Decision Date August 16, 2001
Days to Decision 78 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
52d faster than avg
Panel avg: 130d · This submission: 78d
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 K011667.
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