Cleared Traditional

K050294 - COOK IRELAND SONNET POLYPECTOMY SNARE

K050294 is an FDA 510(k) clearance for COOK IRELAND SONNET POLYPECTOMY SNARE, manufactured by Cook Ireland, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K050294 · Cook Ireland, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
52d
Days
Class 2
Risk

K050294 is an FDA 510(k) clearance for the COOK IRELAND SONNET POLYPECTOMY SNARE. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Cook Ireland, Ltd. (Limerick, IE). The FDA issued a Cleared decision on March 31, 2005 after a review of 52 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 Cook Ireland, Ltd. devices

FDA 510(k) Submission Details - K050294

510(k) Number K050294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2005
Decision Date March 31, 2005
Days to Decision 52 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 131d · This submission: 52d
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 56
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K050294.
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
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INJECTOR NEEDLE/SNARE
K040961 · United States Endoscopy Group, Inc. · Jul 2004
ROTOSNARE
K992477 · Inscope, LLC · Aug 1999
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K971275 · Mill-Rose Laboratory · May 1997