Itp Innovative Tomography Products GmbH · Class II · Cleared Jan 20, 2023
| K-number | K222462 |
| Device name | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10) |
| Applicant | Itp Innovative Tomography Products GmbH |
| Product code | KNW |
| Device class | Class II |
| Decision date | Jan 20, 2023 |
| Decision | Substantially Equivalent |
| Regulation | 876.1075 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov