K231422 is an FDA 510(k) clearance for the Precision GI, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Limaca Medical, Ltd. (En Ha'Emeq, IL). The FDA issued a Cleared decision on August 28, 2023, 103 days after receiving the submission on May 17, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K231422 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 2023 |
| Decision Date | August 28, 2023 |
| Days to Decision | 103 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 |