QAG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Endoscopic Electrosurgical Clip Cutting System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4310
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- To fragment metallic clips and remove them from the digestive tract.
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| Record | Firm | Date |
|---|---|---|
| remOVE System (DEN160014) | Ovesco Endoscopy AG | 2017-12-22 |
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