Submission Details
| 510(k) Number | K062563 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 31, 2006 |
| Decision Date | May 18, 2007 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
FEMTEN CERVICAL TENACULUM
May 2007
Decision
260d
Days
Class 2
Risk
About This 510(k) Submission
K062563 is an FDA 510(k) clearance for the FEMTEN CERVICAL TENACULUM, a Tenaculum, Uterine (Class II — Special Controls, product code HDC), submitted by Fem Suite, LLC (Port Townsend, US). The FDA issued a Cleared decision on May 18, 2007, 260 days after receiving the submission on August 31, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
Device Classification
| Product Code | HDC — Tenaculum, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
Manufacturer
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