Cleared Traditional

K213217 - Disposable hemoclip (FDA 510(k) Clearance)

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

K213217 · Beijing Zksk Technology Co., Ltd. · Gastroenterology & Urology device
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Nov 2022
Decision
411d
Days
Class 2
Risk

K213217 is an FDA 510(k) clearance for the Disposable hemoclip. Classified as Hemostatic Metal Clip For The Gi Tract (product code PKL), Class II - Special Controls.

Submitted by Beijing Zksk Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 14, 2022 after a review of 411 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Beijing Zksk Technology Co., Ltd. devices

Submission Details

510(k) Number K213217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2021
Decision Date November 14, 2022
Days to Decision 411 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
281d slower than avg
Panel avg: 130d · This submission: 411d
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 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.

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