Disposable Hemostatic Clips— 510(k) K232450

Name: FDA 510(k) clearance K232450
Creator: U.S. Food and Drug Administration
Published: 2024-01-26

Substantially Equivalent

Zhejiang Soudon Medical Technology Co., Ltd.

FDA 510(k) clearance K232450 for Disposable Hemostatic Clips, Substantially Equivalent on 2024-01-26. Applicant: Zhejiang Soudon Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Soudon Medical Technology Co., Ltd.
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2023-08-14
Decision date: 2024-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code PKL

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K254069 — Hemoclip (511 series, 543 series)2026-08-10
K260580 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) +4 more2026-05-21
K252270 — Hemoclip2026-04-08
K253734 — Taurus Clip2026-03-12
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)2025-12-18

More clearances from Zhejiang Soudon Medical Technology Co., Ltd.

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K253013 — Disposable Stone Retrieval Balloon Catheter2026-05-08
K253056 — Disposable Stone Extraction Basket2026-04-03
K232442 — Disposable Endoscope Injection Needles2023-11-09
K232476 — Disposable Sphincterotome2023-11-07

Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.