K260962
- 510(k) number
- K260962
- Device name
- Sphincterotome
- Applicant
- Taewoong Medical Co., Ltd. KR
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2026-05-21
- Date received
- 2026-03-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K260962.pdf
Official FDA record: K260962
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.