K983200 is an FDA 510(k) clearance for the INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX. This device is classified as a Needle, Aspiration And Injection, Disposable (Class I - General Controls, product code GAA).
Submitted by Ximed/Prosure/Injectx (San Jose, US). The FDA issued a Cleared decision on December 11, 1998, 88 days after receiving the submission on September 14, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K983200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1998 |
| Decision Date | December 11, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAA — Needle, Aspiration And Injection, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |