Sphincterotome— 510(k) K260962

Name: FDA 510(k) clearance K260962
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Substantially Equivalent

Taewoong Medical Co., Ltd.

FDA 510(k) clearance K260962 for Sphincterotome, Substantially Equivalent on 2026-05-21. Applicant: Taewoong Medical Co., Ltd.. Device class: 2.

Summary

Taewoong Medical filed the Sphincterotome under KNS, endoscopic electrosurgical units with or without accessories. The device name is generic.

Class II, 21 CFR 876.4300. Gastroenterology and Urology is both the classification panel and the review panel. It was a Traditional 510(k).

Taewoong filed from Gimpo-Si, South Korea. The decision came 59 calendar days after receipt (March 23 to May 21, 2026).

Clearance details

Applicant: Taewoong Medical Co., Ltd.
Product code: Product code KNS
Device class: Class 2
Regulation: 21 CFR 876.4300
Advisory panel: Gastroenterology, Urology
Date received: 2026-03-23
Decision date: 2026-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gimpo-Si, KR

Download summary PDF View on FDA.gov ↗

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K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)2025-11-25
K250945 — Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) +3 more2025-10-17
K250351 — Single Use Electrosurgical Knife (3 models)2025-10-10

More clearances from Taewoong Medical Co., Ltd.

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K252648 — Niti-S SPAXUS Stent2026-03-13
K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent2025-12-29
K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent2025-10-30
K250663 — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent2025-03-31
K223067 — Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent2023-06-14

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.