K910577 is an FDA 510(k) clearance for the EDWARDS-WALLACE BOURNE HALL CATHETER. This device is classified as a Cannula, Intrauterine Insemination (Class II - Special Controls, product code MFD).
Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on May 9, 1991, 87 days after receiving the submission on February 11, 1991.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5250.
| 510(k) Number | K910577 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1991 |
| Decision Date | May 09, 1991 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | MFD — Cannula, Intrauterine Insemination |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5250 |