K040110 is an FDA 510(k) clearance for the EASY LOOP, MODEL EZL-01. This device is classified as a Rod, Colostomy (Class II - Special Controls, product code EZP).
Submitted by Tools For Surgery, LLC (Stony Brook, US). The FDA issued a Cleared decision on March 24, 2004, 64 days after receiving the submission on January 20, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4270.
| 510(k) Number | K040110 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2004 |
| Decision Date | March 24, 2004 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZP - Rod, Colostomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4270 |