K860582 is an FDA 510(k) clearance for the TBI NEEDLE. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).
Submitted by Hobbs Medical, Inc. (Stafford Springs, US). The FDA issued a Cleared decision on March 4, 1986, 14 days after receiving the submission on February 18, 1986.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K860582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 1986 |
| Decision Date | March 04, 1986 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |