Wilson-Cook Medical, Inc. · Class II · Cleared Jan 17, 2025
| K-number | K243568 |
| Device name | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord |
| Applicant | Wilson-Cook Medical, Inc. |
| Product code | KNS |
| Device class | Class II |
| Decision date | Jan 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.4300 |
The Teslatome Bipolar Sphincterotome is an endoscopic electrosurgical device used to access and cannulate the biliary duct system and perform sphincterotomy procedures. It can aid in bridging difficult strictures during ERCP and enable wire-guided selective cannulation. The Tesla BiCord Active Cord connects the sphincterotome to compatible electrosurgical generators to deliver cutting current.
The device features a three-ring handle, tri-lumen catheter, and cutting wire connected to an electrosurgical generator via the Tesla BiCord active cord. The multi-lumen catheter allows contrast injection and passage of guidewires through proximal ports. The Teslatome and BiCord share identical technological characteristics with the predicate device K192339.
Not stated in this summary.
The subject device is substantially equivalent because it has the same technological characteristics as the predicate device K192339 and performs identical intended uses (cannulation, sphincterotomy, difficult stricture bridging, and wire-guided selective cannulation). Non-clinical testing for seal strength, functional performance after distribution simulation, current carrying capacity, device burnout, neutral electrode thermal performance, and pushability demonstrated adherence to the manufacturer's quality and risk management systems, confirming safety and effectiveness are maintained.
View the full FDA submission: accessdata.fda.gov