510(k) K243821
K243821 is an FDA 510(k) premarket notification submitted by A.M.I. Agency For Medical Innovations GmbH for the device "i-Cut". The FDA issued a decision of Substantially Equivalent on April 25, 2025. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2025
- Date Received
- December 12, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laparoscope, Gynecologic (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.1720
- Review Panel
- OB
- Submission Type