K951533 is an FDA 510(k) clearance for the EASI-LAV PEDIATRIC / ADULT 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 Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on July 5, 1995, 93 days after receiving the submission on April 3, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K951533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1995 |
| Decision Date | July 05, 1995 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KDH — Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |