K911844 is an FDA 510(k) clearance for the HYSTEROFLATOR 1500. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by F.M. Wiest USA, Inc. (Oradel, US). The FDA issued a Cleared decision on November 21, 1991, 210 days after receiving the submission on April 25, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K911844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1991 |
| Decision Date | November 21, 1991 |
| Days to Decision | 210 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 |