K915572 is an FDA 510(k) clearance for the BECTON DICKINSON MODIFIED MENGHINI NEEDLE. This device is classified as a Needle, Aspiration And Injection, Reusable (Class I - General Controls, product code GDM).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 3, 1992, 53 days after receiving the submission on December 12, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K915572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1991 |
| Decision Date | February 03, 1992 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GDM — Needle, Aspiration And Injection, Reusable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |