CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems— 510(k) K220040
Substantially EquivalentMedos International SARL
FDA 510(k) clearance K220040 for CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems, Substantially Equivalent on 2022-07-14. Applicant: Medos International SARL. Device class: 2.
Clearance details
- Applicant
- Medos International SARL
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Locle, CH
Recent devices under product code HCG
view allMore clearances from Medos International SARL
view allAdverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K220040
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220040.
Data sourced from openFDA. This site is unofficial and independent of the FDA.