K110766 is an FDA 510(k) clearance for the KOLPLUX SYSTEM, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Kolplast CI Ltda (Crofton, US). The FDA issued a Cleared decision on September 15, 2011, 181 days after receiving the submission on March 18, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K110766 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 18, 2011 |
| Decision Date | September 15, 2011 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIB — Speculum, Vaginal, Nonmetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |