K944384 is an FDA 510(k) clearance for the ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG, a Probe And Director, Gastro-urology (Class I — General Controls, product code FGM), submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on February 15, 1995, 161 days after receiving the submission on September 7, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.
| 510(k) Number | K944384 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 1994 |
| Decision Date | February 15, 1995 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FGM — Probe And Director, Gastro-urology |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 876.4730 |