K173489 is an FDA 510(k) clearance for the GYN-Pump PH304. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on March 28, 2018, 135 days after receiving the submission on November 13, 2017.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K173489 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | March 28, 2018 |
| Days to Decision | 135 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIG — Insufflator, Hysteroscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1700 |