K980096 is an FDA 510(k) clearance for the OAC (OPTICAL ASPIRATING CURETTE). This device is classified as a Curette, Uterine (Class I - General Controls, product code HCY).
Submitted by Imagyn Medical Technologies, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on May 1, 1998, 112 days after receiving the submission on January 9, 1998.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K980096 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1998 |
| Decision Date | May 01, 1998 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HCY — Curette, Uterine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 884.4530 |