Cleared Traditional

K220790 - Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220790 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Gastroenterology & Urology device
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Jun 2022
Decision
102d
Days
Class 2
Risk

K220790 is an FDA 510(k) clearance for the Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Yangzhou Fartley Medical Instrument Technology Co., Ltd. (Yangzhou, CN). The FDA issued a Cleared decision on June 27, 2022 after a review of 102 days - within the typical 510(k) review window.

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 Yangzhou Fartley Medical Instrument Technology Co., Ltd. devices

Submission Details

510(k) Number K220790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2022
Decision Date June 27, 2022
Days to Decision 102 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
28d faster than avg
Panel avg: 130d · This submission: 102d
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 Consultant

Shanghai Thinkwell Consulting Co., Ltd.
Ethan Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FDI Snare, Flexible

All 62
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K220790.
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K212860 · STERIS Corporation · Oct 2021