QAG — Endoscopic Electrosurgical Clip Cutting System Class II
FDA product code QAG covers "Endoscopic Electrosurgical Clip Cutting System", a Class II medical device regulated under 21 CFR 876.4310. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QAG
- Device Class
- Class II
- Regulation Number
- 876.4310
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
To fragment metallic clips and remove them from the digestive tract.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN160014 | ovesco endoscopy | remOVE System | December 22, 2017 |