K111013 is an FDA 510(k) clearance for the ACEM, a Cord, Electric, For Endoscope (Class II — Special Controls, product code FFZ), submitted by Sandhill Scientific, Inc. (Boulder, US). The FDA issued a Cleared decision on December 19, 2011, 252 days after receiving the submission on April 11, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K111013 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2011 |
| Decision Date | December 19, 2011 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFZ — Cord, Electric, For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |