K242128 is an FDA 510(k) clearance for the Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle). This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Xaga Surgical (Helsingborg, SE). The FDA issued a Cleared decision on February 27, 2025, 223 days after receiving the submission on July 19, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K242128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2024 |
| Decision Date | February 27, 2025 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |