QGY — Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera Class II

FDA Device Classification

FDA product code QGY covers "Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
QGY
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
SU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190367smith and nephewSmith & Nephew Tablet ApplicationMay 21, 2019