K974028 is an FDA 510(k) clearance for the STARGATE FALLOPOSCOPY CATHETER, TRIFURCATED IRRIGATION TUBING, a Falloposcope (Class II — Special Controls, product code MKO), submitted by Conceptus, Inc. (San Carlos, US). The FDA issued a Cleared decision on January 21, 1998, 90 days after receiving the submission on October 23, 1997. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.
| 510(k) Number | K974028 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 1997 |
| Decision Date | January 21, 1998 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MKO — Falloposcope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1690 |