K083840 is an FDA 510(k) clearance for the MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE, a Endoscope, Rigid (Class II — Special Controls, product code GCM), submitted by Msi Medserv International Deutschland GmbH (Pfullendorf, DE). The FDA issued a Cleared decision on September 28, 2009, 278 days after receiving the submission on December 24, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K083840 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 24, 2008 |
| Decision Date | September 28, 2009 |
| Days to Decision | 278 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCM — Endoscope, Rigid |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |