K260380
- 510(k) number
- K260380
- Device name
- Mendit
- Applicant
- Escala Medical, Ltd. IL
- Product code
- PBQ — Fixation, Non-Absorbable Or Absorbable, For Pelvic
- Decision date
- 2026-03-04
- Date received
- 2026-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K260380.pdf
Official FDA record: K260380
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.