Endoscopic Electrosurgical Clip Cutting System
The Endoscopic Electrosurgical Clip Cutting System is a gastrointestinal endoscopic device used to fragment metallic clips and remove them from the digestive tract, used in scenarios where previously placed endoscopic clips need to be removed. It is classified as a Class 2 device under regulation 876.4310, requiring 510(k) premarket notification, falling within the Obstetrics/Gynecology (OB) medical specialty with Gastroenterology/Urology (GU) review. The product code is QAG. It is not an implant and is not life-sustaining.
Basic Information
- Product Code
- QAG
- Device Class
- FDA class 2
- Regulation Number
- 876.4310
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
To fragment metallic clips and remove them from the digestive tract.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN160014 | remOVE System | Dec 22, 2017 | Unknown | OVESCO ENDOSCOPY AG |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.