DeviceClearance

Product code QGY— Gastroenterology, Urology

Smith & Nephew Tablet Application

Classification name
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.”

— U.S. Food and Drug Administration, device classification record for product code QGY under 21 CFR 876.1500, via openFDA

Market context for product code QGY

FDA has cleared 1 device under product code QGY, all in 2019, 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 QGY

Recent clearances under product code QGY

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