CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
FDA 510(k) clearance K220040 · decided 2022-07-14
Clearance details
- K-number
- K220040
- Device name
- CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2022-01-05
- Decision date
- 2022-07-14
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Le Locle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X recall (Z-0434-2026) | Cerenovus Inc | 2025-11-13 |