K012864 is an FDA 510(k) clearance for the INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on October 24, 2001, 58 days after receiving the submission on August 27, 2001.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K012864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2001 |
| Decision Date | October 24, 2001 |
| Days to Decision | 58 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 |