Cleared Traditional

K220089 - Disposable Polyp Snare (FDA 510(k) Clearance)

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

K220089 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2022
Decision
254d
Days
Class 2
Risk

K220089 is an FDA 510(k) clearance for the Disposable Polyp Snare. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Jiangsu Vedkang Medical Science and Technology Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on September 22, 2022 after a review of 254 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 Jiangsu Vedkang Medical Science and Technology Co., Ltd. devices

Submission Details

510(k) Number K220089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2022
Decision Date September 22, 2022
Days to Decision 254 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
124d slower than avg
Panel avg: 130d · This submission: 254d
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

Shenzhen Joyantech Consulting Co., Ltd.
Joyce Yang

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 K220089.
Advanced Tissue Resection Device
K251692 · Micro-Tech (Nanjing) Co., Ltd. · Feb 2026
Polypectomy Snare
K221713 · Hangzhou AGS MedTech Co., Ltd. · Mar 2023
CORE-SNARE
K220846 · Incore Co., Ltd. · Nov 2022
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
K220790 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jun 2022
Disposable Polypectomy Snare
K213222 · Beijing Zksk Technology Co., Ltd. · Jun 2022
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