Clearance Summary
Retraxil received FDA 510(k) clearance under submission number K243910, sponsored by Kulzer, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2025-09-24.
- Submission: K243910
- Applicant / Sponsor: Kulzer, LLC
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2025-09-24
Classification & Regulation
This clearance is catalogued under FDA product code MVL , within the Unknown review panel as a device.