# K243568: Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 17, 2025 after 60 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910722 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192339: TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord, Wilson-Cook Medical, Inc. (2020) Summary page 5.

## Recalls of this device
- Dec 18, 2025 · Class II · Z-1362-2026: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

## Indications for use
This device is used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. Also indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts. Tesla BiCord Active Cord: This device is used to connect the Teslatome Bipolar Sphincterotome to compatible electrosurgical generators.

Source page: https://510kreport.com/device/K243568
Methodology: https://510kreport.com/methodology