i-Cut
FDA 510(k) clearance K243821 · decided 2025-04-25
Clearance details
- K-number
- K243821
- Device name
- i-Cut
- Applicant
- A.M.I. Agency For Medical Innovations GmbH
- Decision
- Substantially Equivalent
- Date received
- 2024-12-12
- Decision date
- 2025-04-25
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Feldkirch, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.