Cleared Traditional

Disposable Hemostatic Clips (K232450) - FDA 510(k) Clearance

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

K232450 · Zhejiang Soudon Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Jan 2024
Decision
165d
Days
Class 2
Risk

K232450 is an FDA 510(k) clearance for the Disposable Hemostatic Clips. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Zhejiang Soudon Medical Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 26, 2024 after a review of 165 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 Zhejiang Soudon Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K232450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date January 26, 2024
Days to Decision 165 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
35d slower than avg
Panel avg: 130d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKL Hemostatic Metal Clip For The Gi Tract
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4400
Definition Clip Placement Within The Gastrointestinal (gi) Tract For The Purpose Of Endoscopic Marking, Hemostasis For Mucosal/sub-mucosal Defects, Bleeding Ulcers, Arteries, Polyps, Diverticula In The Colon, Prophylactic Clipping, Anchoring Feeding Tubes, Supplemental Closure Method Of Luminal Perforations.
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 Vanhe Consulting Co., Ltd.
Nick 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 - PKL Hemostatic Metal Clip For The Gi Tract

All 51
Devices cleared under the same product code (PKL) and FDA review panel - the closest regulatory comparables to K232450.
Disposable Hemostatic Clips
K232969 · Ningbo Xinwell Medical Technology Co., Ltd. · Jun 2024
Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR)
K240617 · Olympus Medical Systems Corp. · Jun 2024
Disposable Dual Action Tissue Closure Device
K233772 · Mirco-Tech (Nanjing) Co., Ltd. · Mar 2024
Disposable Hemoclip (AF series)
K231633 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jan 2024
Disposable Hemoclip
K230004 · Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Jul 2023
Disposable Endoscopic Hemoclip
K222146 · Jiangsu Vedkang Medical Science and Technology Co., Ltd. · Mar 2023