K071754 is an FDA 510(k) clearance for the NEO-VAGINA SURGERY SET AND ACCESSORIES. This device is classified as a Dilator, Vaginal (Class II - Special Controls, product code HDX).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on January 7, 2009, 559 days after receiving the submission on June 28, 2007.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3900.
| 510(k) Number | K071754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2007 |
| Decision Date | January 07, 2009 |
| Days to Decision | 559 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDX — Dilator, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3900 |