K012935 is an FDA 510(k) clearance for the THECURVE, ITEM 507, a Cannula, Intrauterine Insemination (Class II — Special Controls, product code MFD), submitted by Select Medical Systems, Inc. (Williston, US). The FDA issued a Cleared decision on October 11, 2001, 41 days after receiving the submission on August 31, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K012935 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 2001 |
| Decision Date | October 11, 2001 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MFD — Cannula, Intrauterine Insemination |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5250 |