K024120 is an FDA 510(k) clearance for the MODIFICATION TO TEMNO BIOPSY NEEDLES, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Allegiance Healthcare Corp. (Mcgaw Park, US). The FDA issued a Cleared decision on January 15, 2003, 30 days after receiving the submission on December 16, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K024120 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 16, 2002 |
| Decision Date | January 15, 2003 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |