K000620 is an FDA 510(k) clearance for the PBN FALLOPIAN TUBE CATHETER SYSTEM. This device is classified as a System, Intrafallopian Cannula (Class II - Special Controls, product code MDG).
Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 30, 2000, 249 days after receiving the submission on February 24, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K000620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 24, 2000 |
| Decision Date | October 30, 2000 |
| Days to Decision | 249 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MDG — System, Intrafallopian Cannula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |