K023272 is an FDA 510(k) clearance for the DISPOSABLE ASPIRATION NEEDLE NA-200H. This device is classified as a Biopsy Needle (Class II - Special Controls, product code FCG).
Submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on December 23, 2002, 83 days after receiving the submission on October 1, 2002.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K023272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2002 |
| Decision Date | December 23, 2002 |
| Days to Decision | 83 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 |