Cleared Special

K182909 - Roth Net Retriever Product Line

K182909 is the FDA 510(k) clearance for Roth Net Retriever Product Line by United States Endoscopy Group, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Special 510(k) pathway after a 35-day FDA review.

K182909 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Nov 2018
Decision
35d
Days
Class 2
Risk

K182909 is an FDA 510(k) clearance for the Roth Net Retriever Product Line. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on November 21, 2018 after a review of 35 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all United States Endoscopy Group, Inc. devices

Submission Details

510(k) Number K182909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2018
Decision Date November 21, 2018
Days to Decision 35 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 130d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 36
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