K110636 is an FDA 510(k) clearance for the TULA IONTOPHORESIS SYSTEM. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Acclarent, Inc. (Rmenlo Park, US). The FDA issued a Cleared decision on June 16, 2011, 104 days after receiving the submission on March 4, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K110636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2011 |
| Decision Date | June 16, 2011 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |