K890384 is an FDA 510(k) clearance for the UTERINE CURETTE. This device is classified as a Curette, Uterine (Class I - General Controls, product code HCY).
Submitted by Kinetic Medical Products (Erie, US). The FDA issued a Cleared decision on February 13, 1989, 21 days after receiving the submission on January 23, 1989.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K890384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1989 |
| Decision Date | February 13, 1989 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HCY — Curette, Uterine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4530 |