K992926 is an FDA 510(k) clearance for the GINRAM ENDOCIC SINGLE OVAL PORT (MODEL NO. 720195). This device is classified as a Curette, Suction, Endometrial (and Accessories) (Class II — Special Controls, product code HHK).
Submitted by Ri Mos. S.R.L. (Concord, US). The FDA issued a Cleared decision on October 26, 1999, 56 days after receiving the submission on August 31, 1999.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1175.
| 510(k) Number | K992926 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 1999 |
| Decision Date | October 26, 1999 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHK — Curette, Suction, Endometrial (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1175 |