K983889 is an FDA 510(k) clearance for the HYS-SURGIFLATOR 150P. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by W.O.M. World of Medicine GmbH (Mansfield, US). The FDA issued a Cleared decision on January 14, 1999, 73 days after receiving the submission on November 2, 1998.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K983889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1998 |
| Decision Date | January 14, 1999 |
| Days to Decision | 73 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 |