510(k) K243245 ยท GEH Unit, Cryosurgical, Accessories
IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Oct 18, 2024 |
| Received | Oct 11, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243245
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.