510(k) K243910
K243910 is an FDA 510(k) premarket notification submitted by Kulzer, LLC for the device "Retraxil". The FDA issued a decision of Substantially Equivalent on September 24, 2025. The device falls under product code MVL (Cord, Retraction), a Class U device. Kulzer, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2025
- Date Received
- December 19, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cord, Retraction
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type