K932114 is an FDA 510(k) clearance for the TUBAL LUMEN SUPPORT, a Prosthesis, Fallopian Tube (Class II — Special Controls, product code HFJ), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on September 27, 1994, 512 days after receiving the submission on May 3, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.3650.
| 510(k) Number | K932114 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 03, 1993 |
| Decision Date | September 27, 1994 |
| Days to Decision | 512 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HFJ — Prosthesis, Fallopian Tube |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.3650 |