# K192339: TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

- Pathway: 510(k) (Traditional)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 30, 2020 after 155 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910722 (1991). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141991: Single Use Preloaded Sphincterotome V (Distal Wireguided); Single Use SP, Olympus Medical Systems Copr. (2015) Summary page 4.
- K172288: Fusion OMNI Sphincterotome, Wilson-Cook Medical Inc./Cook Endoscopy (2018) Summary page 4.

## Most influential descendants
- K243568: Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (2025), 0 descendants of its own

## Indications for use
The TeslaTome Bipolar Sphincterotome is intended for cannulation of the ductal system and sphincterotomy. If preloaded, also aids in bridging difficult strictures during ERCP (endoscopic retrograde cholangiopancreatography). Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts. The Tesla Bipolar Active Cord is used to connect the TeslaTome Bipolar Sphincterotome to compatible electrosurgical generators.

Source page: https://510kreport.com/device/K192339
Methodology: https://510kreport.com/methodology