K060320 is an FDA 510(k) clearance for the FEMECC ENDOCERVICAL CURETTE, a Sampler, Endocervical (Class II — Special Controls, product code PCF), submitted by Femspec LLC (Port Townsend, US). The FDA issued a Cleared decision on July 28, 2006, 170 days after receiving the submission on February 8, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1050.
| 510(k) Number | K060320 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 08, 2006 |
| Decision Date | July 28, 2006 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PCF — Sampler, Endocervical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1050 |
| Definition | Obtains Tissue Samples From The Endocervical Canal For Histological Analysis. |