K831212 is an FDA 510(k) clearance for the ENDOSCANN. This device is classified as a Aspirator, Endometrial (Class II - Special Controls, product code HFF).
Submitted by Axcan Scientific Corp. (Walker, US). The FDA issued a Cleared decision on June 15, 1984, 428 days after receiving the submission on April 14, 1983.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1060.
| 510(k) Number | K831212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1983 |
| Decision Date | June 15, 1984 |
| Days to Decision | 428 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFF — Aspirator, Endometrial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1060 |