K013597 is an FDA 510(k) clearance for the TAMPONADE UTERINE BALLOON CATHETER SET, a Instrument, Manual, Specialized Obstetric-gynecologic (Class II — Special Controls, product code KNA), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on April 17, 2002, 168 days after receiving the submission on October 31, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K013597 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2001 |
| Decision Date | April 17, 2002 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNA — Instrument, Manual, Specialized Obstetric-gynecologic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |