K243910
- 510(k) number
- K243910
- Device name
- Retraxil
- Applicant
- Kulzer, LLC IN · US
- Product code
- MVL — Cord, Retraction
- Decision date
- 2025-09-24
- Date received
- 2024-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243910.pdf
Official FDA record: K243910
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.