K252442
- 510(k) number
- K252442
- Device name
- Kii Structural Balloon Access System
- Applicant
- Applied Medical Resources Corp. CA · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2025-10-31
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252442.pdf
Official FDA record: K252442
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.