K141794 is an FDA 510(k) clearance for the ENDO-MARYLAND DISSECTOR. This device is classified as a Forceps, Biopsy, Electric (Class II - Special Controls, product code KGE).
Submitted by Ovesco Endoscopy AG (Tuebingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on November 19, 2014, 140 days after receiving the submission on July 2, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K141794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2014 |
| Decision Date | November 19, 2014 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KGE - Forceps, Biopsy, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |