K232635
- 510(k) number
- K232635
- Device name
- IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
- Applicant
- Boston Scientific MN · US
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2023-11-22
- Date received
- 2023-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232635.pdf
Official FDA record: K232635
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.