K854725 is an FDA 510(k) clearance for the HURWITZ AMNIOCENTESIS NEEDLE. This device is classified as a Sampler, Amniotic Fluid (amniocentesis Tray) (Class I - General Controls, product code HIO).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on March 17, 1986, 115 days after receiving the submission on November 22, 1985.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1550.
| 510(k) Number | K854725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 1985 |
| Decision Date | March 17, 1986 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HIO — Sampler, Amniotic Fluid (amniocentesis Tray) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.1550 |