K160664 is an FDA 510(k) clearance for the Aqueduct 100 Cervical Dilator. This device is classified as a Catheter, Balloon, Dilation Of Cervical Canal (Class II - Special Controls, product code PON).
Submitted by Gtimd, LLC (Amherst, US). The FDA issued a Cleared decision on August 1, 2016, 145 days after receiving the submission on March 9, 2016.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4260. Mechanical Dilation And Softening Of The Cervix..
| 510(k) Number | K160664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2016 |
| Decision Date | August 01, 2016 |
| Days to Decision | 145 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PON - Catheter, Balloon, Dilation Of Cervical Canal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4260 |
| Definition | Mechanical Dilation And Softening Of The Cervix. |