Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
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Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
- Page Type
- Product Code
- 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
- Physical State
- Electrosurgical forceps and may include accessories.
- Technical Method
- The device is deployed through a bronchoscope.
- Target Area
- Tracheobronchial tree.
- Regulation Medical Specialty
- Gastroenterology and Urology
- Review Panel
- Anesthesiology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 876.4300
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 876.4300 Endoscopic electrosurgical unit and accessories
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a) Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.
(b) Classification. Class II (performance standards).