IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
FDA 510(k) clearance K232635 · decided 2023-11-22
Clearance details
- K-number
- K232635
- Device name
- IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2023-08-30
- Decision date
- 2023-11-22
- Days to decision
- 84 days
- Clearance type
- Special
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are inten recall (Z-1686-2025) | Boston Scientific Corporation | 2025-04-29 |