K092870 is an FDA 510(k) clearance for the NON-STERILE DISPOSABLE VAGINAL SPECULUM, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Kunshan Deyi Plastic Co., Ltd. (Echo, US). The FDA issued a Cleared decision on February 16, 2010, 151 days after receiving the submission on September 18, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K092870 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 18, 2009 |
| Decision Date | February 16, 2010 |
| Days to Decision | 151 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 |