K991235 is an FDA 510(k) clearance for the SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC). This device is classified as a Monitor, Pressure, Intrauterine (Class II - Special Controls, product code KXO).
Submitted by Ludlow Technical Products (Chicopee, US). The FDA issued a Cleared decision on July 8, 1999, 87 days after receiving the submission on April 12, 1999.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K991235 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 1999 |
| Decision Date | July 08, 1999 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KXO — Monitor, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |