510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QGYClass II

Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QGY is the FDA product code for Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QGY
Device name
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
FDA definition
Device is intended for wireless control of settings for surgical or endoscopic camera control unit and patient information system.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QGY

By decision year
1 clearance under product code QGY with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QGY by decision year
YearClearances
20191

Applicants with the most clearances

Product code QGY
Applicants holding the most 510(k) clearances under product code QGY
ApplicantClearances
Smith & Nephew, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code