K212423 is an FDA 510(k) clearance for the EndoDrill® Model X. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Bibbinstruments AB (Lund, SE). The FDA issued a Cleared decision on March 29, 2023, 602 days after receiving the submission on August 4, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K212423 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2021 |
| Decision Date | March 29, 2023 |
| Days to Decision | 602 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCG - Biopsy Needle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |