510(k) K243568 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jan 17, 2025 |
| Received | Nov 18, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243568
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 13, 2026 | Wilson-Cook Medical Inc. Teslatome Bipolar Sphincterotomes
REF: TESLA-B2535-260
Model Number: G60784
UDI-DI code: 00827002607842
REF: TESLA-B2535-450
Model Number: G60785
UDI-DI code: 00827002607859
These devices are used f Open, Classified |
KNS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.