K252208
- 510(k) number
- K252208
- Device name
- JFord Speculum Sleeve
- Applicant
- Ford Medtech, LLC NY · US
- Product code
- HIB — Speculum, Vaginal, Nonmetal
- Decision date
- 2026-03-06
- Date received
- 2025-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252208.pdf
Official FDA record: K252208
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.