K942177 is an FDA 510(k) clearance for the FOLEY CATHETERIZATION TRAY. This device is classified as a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II - Special Controls, product code FCM).
Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on September 8, 1994, 127 days after receiving the submission on May 4, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K942177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1994 |
| Decision Date | September 08, 1994 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |