K242228
- 510(k) number
- K242228
- Device name
- Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
- Applicant
- Triopsy Medical, Inc. MN · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2025-01-10
- Date received
- 2024-07-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K242228.pdf
Official FDA record: K242228
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.