K791633 is an FDA 510(k) clearance for the UC-2000 UTERINE CATHERIZATION SYSTEM. This device is classified as a Recorder, Pressure, Intrauterine (Class II - Special Controls, product code HFO).
Submitted by Life Support, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979, 27 days after receiving the submission on August 21, 1979.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2700.
| 510(k) Number | K791633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 1979 |
| Decision Date | September 17, 1979 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HFO — Recorder, Pressure, Intrauterine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2700 |