510(k) K232635 · GEH Unit, Cryosurgical, Accessories
IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Nov 22, 2023 |
| Received | Aug 30, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232635
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2025 | Boston Scientific Corporation IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100.
The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. Open, Classified |
GEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.