K924549 is an FDA 510(k) clearance for the TRI-MED QUICK-STEP(TM) RECTAL TUBE. This device is classified as a Catheter, Rectal (Class II - Special Controls, product code GBT).
Submitted by Tri-Med Specialties, Inc. (Overland Park, US). The FDA issued a Cleared decision on February 10, 1994, 519 days after receiving the submission on September 9, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K924549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 1992 |
| Decision Date | February 10, 1994 |
| Days to Decision | 519 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | GBT — Catheter, Rectal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |