Cleared Traditional

K213222 - Disposable Polypectomy Snare

K213222 is an FDA 510(k) clearance for Disposable Polypectomy Snare, manufactured by Beijing Zksk Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FDI cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K213222 · Beijing Zksk Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
250d
Days
Class 2
Risk

K213222 is an FDA 510(k) clearance for the Disposable Polypectomy Snare. Classified as Snare, Flexible (product code FDI), Class II - Special Controls.

Submitted by Beijing Zksk Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on June 6, 2022 after a review of 250 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 Beijing Zksk Technology Co., Ltd. devices

FDA 510(k) Submission Details - K213222

510(k) Number K213222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date June 06, 2022
Days to Decision 250 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
120d slower than avg
Panel avg: 130d · This submission: 250d
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 Consultant

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 43
Devices cleared under the same product code (FDI) and FDA review panel - the closest regulatory comparables to K213222.
CORE-SNARE
K220846 · Incore Co., Ltd. · Nov 2022
Disposable Polyp Snare
K220089 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Sep 2022
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
K220790 · Yangzhou Fartley Medical Instrument 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
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