K042901 is an FDA 510(k) clearance for the ENDOMARK STERILE INDIA INK, a Marker, Colon (Class II — Special Controls, product code NBG), submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on March 16, 2005, 147 days after receiving the submission on October 20, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K042901 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 2004 |
| Decision Date | March 16, 2005 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NBG — Marker, Colon |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |