Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree

QEC · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.4300

Classification

FDA Product Code: QEC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.4300
Review panel: AN
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown