QEC — Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree Class II
FDA product code QEC covers "Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree", a Class II medical device regulated under 21 CFR 876.4300. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QEC
- Device Class
- Class II
- Regulation Number
- 876.4300
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
An endoscopic electrosurgical forceps and accessories used with an endoscope to electrosurgically collect tissue for biopsy and to perform electrosurgical hemostasis within the tracheobronchial tree
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K173495 | olympus medical systems | Single Use Hot Biopsy Forceps FD-231 | November 30, 2018 |