K122653 is an FDA 510(k) clearance for the MIC-KEY SF LOW PROFILE GASTROSTOMY TUBE AND ACCESSORIES. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).
Submitted by Kimberly Clark Corporation (Roswell, US). The FDA issued a Cleared decision on June 26, 2013, 299 days after receiving the submission on August 31, 2012.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.
| 510(k) Number | K122653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 31, 2012 |
| Decision Date | June 26, 2013 |
| Days to Decision | 299 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 |