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
| Device Type ID | 218 |
| Device Name | Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree |
| Physical State | Electrosurgical Forceps And May Include Accessories. |
| Technical Method | The Device Is Deployed Through A Bronchoscope. |
| Target Area | Tracheobronchial Tree. |
| Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Anesthesiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.4300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 218 |
| Device | Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree |
| Product Code | QEC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscopic Electrosurgical Unit And Accessories. |
| CFR Regulation Number | 876.4300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |