510(k) K183385 ยท OAB Low Energy Direct Current Thermal Ablation System
NanoKnife System
| Applicant | Angiodynamics, Marlborough MA, US |
| Decision | Substantially Equivalent, Jun 18, 2019 |
| Received | Dec 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Angiodynamics, Inc. NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue.
Catalog Number: 20400111
UPN: H787204001110 Open, Classified |
OAB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.