DeviceClearance

Product code QEC— Gastroenterology, Urology

Single Use Hot Biopsy Forceps FD-231

Classification name
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
Device class
Class 2
Regulation
21 CFR 876.4300
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code QEC under 21 CFR 876.4300, via openFDA

Market context for product code QEC

FDA has cleared 1 device under product code QEC, all in 2018, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QEC

Recent clearances under product code QEC

Data sourced from openFDA. This site is unofficial and independent of the FDA.