K233294 is an FDA 510(k) clearance for the Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Itp Innovative Tomography Products GmbH (Bochum, DE). The FDA issued a Cleared decision on June 18, 2024, 263 days after receiving the submission on September 29, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K233294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | June 18, 2024 |
| Days to Decision | 263 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KNW - Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |