K243568
- 510(k) number
- K243568
- Device name
- Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
- Applicant
- Wilson-Cook Medical, Inc. NC · US
- Product code
- KNS — Unit, Electrosurgical, Endoscopic (With Or Without A
- Decision date
- 2025-01-17
- Date received
- 2024-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243568.pdf
Official FDA record: K243568
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.