Cleared Traditional

K213223 - Multi-Band Ligator

K213223 is an FDA 510(k) clearance for Multi-Band Ligator, manufactured by Beijing Zksk Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FHN cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K213223 · Beijing Zksk Technology Co., Ltd. · Gastroenterology & Urology device
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Jun 2022
Decision
250d
Days
Class 2
Risk

K213223 is an FDA 510(k) clearance for the Multi-Band Ligator. Classified as Ligator, Hemorrhoidal (product code FHN), 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 876.4400 - 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 - K213223

510(k) Number K213223 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
119d slower than avg
Panel avg: 131d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FHN Device Classification - Class 2, Special Controls

Product Code FHN Ligator, Hemorrhoidal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
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 - FHN Ligator, Hemorrhoidal

All 19
Devices cleared under the same product code (FHN) and FDA review panel - the closest regulatory comparables to K213223.
Ligation Device
K172985 · Leo Medical Co., Ltd. · Jun 2018
Wi-3 HAL-RAR System
K150718 · Agency For Medical Innovations GmbH · Jun 2015
NEXUS HEMORRHOID LIGATOR
K131282 · Inx Medical · Jul 2013
THD BANDY
K093497 · Thd Spa · Jul 2010
HAEMOBAND MULTI-LIGATOR
K091519 · Haemoband Surgical, Ltd. · Jul 2009
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881 · Sapimed S.P.A. · Sep 2007