K920527 is an FDA 510(k) clearance for the TRI-MED QUICK-STEP GASTRIC LAVAGE KIT. This device is classified as a Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration (Class II - Special Controls, product code KDH).
Submitted by Tri-Med Specialties, Inc. (Overland Park, US). The FDA issued a Cleared decision on September 4, 1992, 213 days after receiving the submission on February 4, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K920527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1992 |
| Decision Date | September 04, 1992 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KDH — Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |