K093508 is an FDA 510(k) clearance for the RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12), a Cannula, Suction, Uterine (Class II — Special Controls, product code HGH), submitted by Womancare Global (Chapel Hill, US). The FDA issued a Cleared decision on March 4, 2010, 112 days after receiving the submission on November 12, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.
| 510(k) Number | K093508 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2009 |
| Decision Date | March 04, 2010 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGH — Cannula, Suction, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5070 |