K243095
- 510(k) number
- K243095
- Device name
- Mammotome AutoCore Single Insertion Core Biopsy System
- Applicant
- Devicor Medical Products, Inc. OH · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2024-10-29
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243095.pdf
Official FDA record: K243095
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.