K131052 is an FDA 510(k) clearance for the TUBECLEAR MODEL 101 (WITH NEW CLEARING STEM NE AND G MODELS). This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Actuated Medical, Inc. (Bellefonte, US). The FDA issued a Cleared decision on August 16, 2013, 123 days after receiving the submission on April 15, 2013.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K131052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2013 |
| Decision Date | August 16, 2013 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNT - Tubes, Gastrointestinal (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5980 |