K862481 is an FDA 510(k) clearance for the CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE. This device is classified as a Needle, Aspiration And Injection, Reusable (Class I - General Controls, product code GDM).
Submitted by CIVCO Medical Instruments Co., Inc. (Kalona, US). The FDA issued a Cleared decision on July 23, 1986, 23 days after receiving the submission on June 30, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K862481 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1986 |
| Decision Date | July 23, 1986 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GDM — Needle, Aspiration And Injection, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |