K243152
- 510(k) number
- K243152
- Device name
- GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device
- Applicant
- Applied Medical Resources Corp. CA · US
- Product code
- HEW — Culdoscope (And Accessories)
- Decision date
- 2025-10-02
- Date received
- 2024-09-30
- 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: K243152.pdf
Official FDA record: K243152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.