Cleared Traditional

K142258 - PolyCatch Retrieval Device

K142258 is an FDA 510(k) clearance for PolyCatch Retrieval Device, manufactured by Medi-Globe Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K142258 · Medi-Globe Corporation · Gastroenterology & Urology device
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Sep 2014
Decision
47d
Days
Class 2
Risk

K142258 is an FDA 510(k) clearance for the PolyCatch Retrieval Device. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Medi-Globe Corporation (Tempe, US). The FDA issued a Cleared decision on September 30, 2014 after a review of 47 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 Medi-Globe Corporation devices

FDA 510(k) Submission Details - K142258

510(k) Number K142258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2014
Decision Date September 30, 2014
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 130d · This submission: 47d
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 K142258.
rescuenet
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K133987 · Boston Scientific Corporation · Jan 2014
MULTI-STAGE SNARE
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