K013437 is an FDA 510(k) clearance for the SF SH CATHETER, MODEL R65-945, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by A & A Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on November 19, 2001, 33 days after receiving the submission on October 17, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K013437 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 17, 2001 |
| Decision Date | November 19, 2001 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LKF — Cannula, Manipulator/injector, Uterine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |