510(k) K251170 ยท FBN Choledochoscope And Accessories, Flexible/Rigid
Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller
| Applicant | Tangent Endoscopy, LLC, Camden DE, US |
| Decision | Substantially Equivalent, Sep 12, 2025 |
| Received | Apr 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251170
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2026 | TANGENT ENDOSCOPY, LLC Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers:
(1) TNG4002-IND.
(2) TNG-4007-6pk. Open, Classified |
FBN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.