K140558 is an FDA 510(k) clearance for the PROCTIGARD, a Protective Coating, Mucoadhesive Application, For The Rectal Mucosa, submitted by Access Pharmaceuticals, Inc. (New York, US). The FDA issued a Cleared decision on July 16, 2014, 133 days after receiving the submission on March 5, 2014. This device falls under the Gastroenterology & Urology review panel.
| 510(k) Number | K140558 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 2014 |
| Decision Date | July 16, 2014 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PHN — Protective Coating, Mucoadhesive Application, For The Rectal Mucosa |
| Device Class | — |
| Definition | Mucoadhesive Application For The Protective Coating Of The Rectal Mucosa. |