K921871 is an FDA 510(k) clearance for the HYSTEROMAT(TM) 3700. This device is classified as a Insufflator, Hysteroscopic (Class II - Special Controls, product code HIG).
Submitted by F.M. Wiest USA, Inc. (Oradell, US). The FDA issued a Cleared decision on December 15, 1994, 969 days after receiving the submission on April 20, 1992.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1700.
| 510(k) Number | K921871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1992 |
| Decision Date | December 15, 1994 |
| Days to Decision | 969 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 |