Cleared Traditional

K190512 - SmartBand EMR Kit

K190512 is the FDA 510(k) clearance for SmartBand EMR Kit by Intelligent Endoscopy. It is a Class 2 Gastroenterology & Urology device (product code FDI) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K190512 · Intelligent Endoscopy · Gastroenterology & Urology device
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Nov 2019
Decision
266d
Days
Class 2
Risk

K190512 is an FDA 510(k) clearance for the SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Intelligent Endoscopy (Clemmons, US). The FDA issued a Cleared decision on November 22, 2019 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intelligent Endoscopy devices

Submission Details

510(k) Number K190512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2019
Decision Date November 22, 2019
Days to Decision 266 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
136d slower than avg
Panel avg: 130d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 40
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K190512.
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
K212860 · STERIS Corporation · Oct 2021
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
K202478 · Boston Scientific Corporation · Oct 2020
Lariat, Hot/Cold Snare
K200745 · United States Endoscopy Group, Inc. · Apr 2020
AcuSnare Polypectomy Snare - Duckbill
K191048 · Wilson-Cook Medical, Inc. · Jul 2019
ClearGrasp Snare
K183289 · Finemedix Co., Ltd. · Mar 2019
Roth Net Retriever Product Line
K182909 · United States Endoscopy Group, Inc. · Nov 2018