Taurus Clip— 510(k) K253734

Name: FDA 510(k) clearance K253734
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Taurus Endoscopy

FDA 510(k) clearance K253734 for Taurus Clip, Substantially Equivalent on 2026-03-12. Applicant: Taurus Endoscopy. Device class: 2.

Clearance details

Applicant: Taurus Endoscopy
Product code: Code PKL
Device class: Class 2
Regulation: 21 CFR 876.4400
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-24
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Strasbourg, FR

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
K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)2025-12-18
K252271 — Hemoclip2025-11-12

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.